1. YAVNE, Israel, Oct. 04, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced a peer-reviewed publication in the Journal of Wound Care of an in vivo head-to-head study comparing EscharEx® and a commercial enzymatic debridement agent in the removal of chronic wound eschar. The study concluded that EscharEx was more effective than the commercially available collagenase in removing the eschar in this wound model.

    The paper, entitled Development of a porcine chronic wound model: Evaluation of a bromelain-based enzymatic debriding agent1, describes the development of a novel porcine eschar model…

    YAVNE, Israel, Oct. 04, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced a peer-reviewed publication in the Journal of Wound Care of an in vivo head-to-head study comparing EscharEx® and a commercial enzymatic debridement agent in the removal of chronic wound eschar. The study concluded that EscharEx was more effective than the commercially available collagenase in removing the eschar in this wound model.

    The paper, entitled Development of a porcine chronic wound model: Evaluation of a bromelain-based enzymatic debriding agent1, describes the development of a novel porcine eschar model and compares the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic debridement agent, with commercially available collagenase-based debridement agent. Study results demonstrated that EscharEx treatment was more effective than the commercially available collagenase agent in debriding eschars in this novel porcine wound model.

    "We are excited to have the study results published in this esteemed journal. The data clearly demonstrate EscharEx was superior to the commercially available enzymatic debriding agent in removing eschar," said Sharon Malka, Chief Executive Officer of MediWound. "The data generated to date, together with the successful interim assessment of our ongoing U.S. phase 2 study to treat patients with venous leg ulcers, give us confidence in our clinical development plan, and we look forward to report data from our phase 2 study in the first half of next year. EscharEx may offer significant benefits for patients and healthcare professionals in the care of chronic wounds, addressing a clear medical need for a rapid and effective non-surgical debridement agent, and we believe it has the potential to change the standard of care in this sizeable market."

    Summary of study results

    The study was conducted in collaboration with investigators from the Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, using a novel porcine wound model designed to evaluate the efficacy of enzymatic debridement agents. The primary objective of the study was to assess the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic agent (second generation EscharEx formulation), and to compare it with a commercially available collagenase debridement agent. Efficacy was evaluated based on the number of treatments of various concentrations of EscharEx and the collagenase agent necessary to achieve complete eschar removal (clinical assessment of at least 95% eschar removal from the center of the wound).

    Key findings from the study included:

    • In all wounds treated with EscharEx and at all concentrations, the wound eschar was completely removed within a maximum of ten 24‑hour applications. A trend towards dose-dependency was observed in the time to complete debridement.
    • None of the wounds treated with collagenase achieved >95% wound eschar removal after ten applications, the maximum number of applications needed to achieve complete debridement with EscharEx.
    • Pairwise comparisons between wounds treated with collagenase and each of the concentrations of EscharEx demonstrated significantly fewer applications required to achieve complete eschar removal with EscharEx (adjusted p<0.05).
    • Analysis of variance comparing mean number of applications required to achieve complete eschar removal also showed significant differences in means in favor of EscharEx (p<0.001).
    • Pairwise comparisons between wounds treated with collagenase and each of the concentrations of EscharEx demonstrated significantly higher percentage of complete eschar removal with the EscharEx at all time points.

    About EscharEx

    EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    EscharEx's active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx is our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.



    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; timing or likelihood of approval by the U.S. Food & Drug Administration (FDA) of a Biologics License Application (BLA) for NexoBrid for treatment of severe burns in the United States following the receipt of a complete response for NexoBrid on June 28, 2021, the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA, including availability of funding from BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic on our business or the economy generally. For example, we are unable to predict how the COVID-19 pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and may impact the response times of governmental agencies, including the FDA, to future regulatory submissions and/or conduct necessary reviews or inspections of our manufacturing facilities, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of our products, including NexoBrid. Other disruptions or potential disruptions of the COVID-19 pandemic include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts or initiatives that may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:   Jeremy Feffer
    Boaz Gur-Lavie    Jeremy Feffer
    Chief Financial Officer  Managing Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.com jeremy@lifesciadvisors.com

    1 https://doi.org/10.12968/jowc.2021.30.Sup9a.VI



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  2. YAVNE, Israel, Sept. 03, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that management will present at the following investor conferences during the month of September 2021.

    2021 Wells Fargo Virtual Healthcare Conference
    Date: Thursday, September 9, 2021
    Presentation Time: 8:00 a.m. Eastern Time

    H.C. Wainwright 23rd Annual Global Investment Conference
    On-demand corporate presentation is available beginning at 7:00 AM ET on Monday, September 13, 2021

    A live webcast of each event will be available on the Events page of the Investors section of the Company's website: www.mediwound.com

    YAVNE, Israel, Sept. 03, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that management will present at the following investor conferences during the month of September 2021.

    2021 Wells Fargo Virtual Healthcare Conference

    Date: Thursday, September 9, 2021

    Presentation Time: 8:00 a.m. Eastern Time

    H.C. Wainwright 23rd Annual Global Investment Conference

    On-demand corporate presentation is available beginning at 7:00 AM ET on Monday, September 13, 2021

    A live webcast of each event will be available on the Events page of the Investors section of the Company's website: www.mediwound.com. A replay of each webcast will be available on the Company's website for approximately 30 days.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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  3. Second Quarter Revenues of $6.1 Million - Increase of 50% Year-over-Year

    Positive Interim Assessment Outcome for EscharEx U.S. Phase II Clinical Study
    No Changes to Study Sample Size – No Safety Concerns Identified

    Conference call begins today at 8:30 am ET

    YAVNE, Israel, Aug. 10, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the second quarter ended June 30, 2021.

    Second Quarter and Recent Weeks Corporate and Financial Highlights:

    • Total revenues for the second quarter of 2021 were $6.1 million, an increase of 50% compared…

    Second Quarter Revenues of $6.1 Million - Increase of 50% Year-over-Year

    Positive Interim Assessment Outcome for EscharEx U.S. Phase II Clinical Study

    No Changes to Study Sample Size – No Safety Concerns Identified

    Conference call begins today at 8:30 am ET

    YAVNE, Israel, Aug. 10, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the second quarter ended June 30, 2021.

    Second Quarter and Recent Weeks Corporate and Financial Highlights:

    • Total revenues for the second quarter of 2021 were $6.1 million, an increase of 50% compared with the second quarter of 2020

    • The Company had $17.2 million in cash and short-term investments as of June 30, 2021

    • Positive outcome of interim assessment for EscharEx U.S. phase II adaptive design study with no changes to study sample size of 120 patients and no safety concerns identified; full study enrollment expected by year-end 2021 and data readout expected in the first half of 2022

    • Received a Complete Response Letter (CRL) from U.S. FDA for NexoBrid biologics license application (BLA); working together with our partners, Vericel and BARDA, towards BLA resubmission

    • Positive top line results from phase III pediatric study (CIDS) for eschar removal of severe thermal burns; met all primary endpoints with a high degree of statistical significance, as well as certain secondary endpoints; the study showed NexoBrid to be safe and well tolerated

    • Initiated a U.S. phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC); phase II investigator-initiated trial in non-melanoma skin cancers running in parallel with data from both expected by year-end of 2021

    "The second quarter of 2021 and the subsequent weeks, have been eventful with positive interim assessment for EscharEx phase II clinical study, FDA feedback on our NexoBrid BLA and positive top line results from NexoBrid phase III pediatric study," said Sharon Malka, Chief Executive Officer of MediWound. "Moving forward with the best possible outcome of the interim assessment for our U.S. phase II adaptive design study of EscharEx, we have made significant progress in advancing our EscharEx development program, and we look forward to additional significant clinical milestones in the months ahead as we complete enrollment in our phase II study and generate data from our phase II pharmacology study later this year. Chronic wounds impact millions of people worldwide and these important catalysts could advance us one step closer to bringing EscharEx to market as an improvement upon the current standard of care in chronic wound management. We are also excited to commence the clinical development program for MW005 in basal cell carcinoma with two phase II trials underway and look forward to providing further updates on their progress later this year."

    Mr. Malka commented further "Though we were disappointed with the receipt of the NexoBrid CRL, we believe the FDA's comments can be addressed, and remain optimistic about the prospects of NexoBrid in the U.S. We are working closely with our partners Vericel and BARDA, to meet with the FDA as soon as possible and provide the FDA with a detailed response to the CRL. Regarding our CIDS pediatric phase III study, we were pleased with the robust clinical data generated, o which met all of its primary endpoints with highly statistically significant results, reinforcing the strong clinical safety and efficacy profile of NexoBrid. We believe that this data will further support our global expansion of NexoBrid as we continue to gain commercial traction in multiple geographies around the world."

    Second Quarter Financial Results

    Revenues for the second quarter of 2021 were $6.1 million, compared with $4.0 million for the second quarter of 2020, an increase of 50%. Product revenues in the second quarter of 2021 were $3.0 million, an increase of 175% compared to $1.1 million for the second quarter of 2020, primarily driven by the procurement of NexoBrid by BARDA for emergency response preparedness and sales increase outside the U.S.

    Gross profit for the second quarter of 2021 was $2.4 million or 39% of net revenues compared to a gross profit of $1.2 million or 30% of net revenues for the second quarter of 2020.

    Research and development expenses for the second quarter of 2021 were $2.7 million, compared with $1.6 million for the second quarter of 2020. The increase was primarily due to EscharEx clinical development program.

    Selling, general and administrative expenses for the second quarter of 2021 were $2.6 million, compared with $2.3 million in the second quarter of 2020. As a percentage of revenues, selling, general and administrative expenses for the second quarter decreased from 57% in the second quarter of 2020 to 43% in the second quarter of 2021

    Operating loss for the second quarter of 2021 was $2.9 million, compared with an operating loss of $2.7 million in the second quarter of 2020.

    The Company posted a net loss of $3.2 million, or $0.12 per share, for the second quarter of 2021 compared with a net loss of $3.1 million, or $0.11 per share, for the second quarter of 2020.

    Adjusted EBITDA, as defined below, for the second quarter of 2021 was a loss of $2.0 million, compared with a loss of $2.1 million for the second quarter of 2020.

    Year-to-Date 2021 Financial Results

    Revenues for the first half of 2021 were $11.9 million compared with $8.5 million in the first half of 2020, an increase of 41%. Product revenues in the first half of 2021 were $5.9 million, an increase of 224% compared to $1.8 million for the first half 2020. .

    Operating loss for the first half of 2021 was $4.8 million, compared with an operating loss of $4.9 million in the first half of 2020.

    The Company's net loss for the first half of 2021 was $6.0 million or $0.22 per share compared with net loss of $5.6 million or $0.20 per share for the first half of 2020.

    Adjusted EBITDA, for the first half of 2021, was a loss of $3.3 million, compared with a loss of $3.9 million for the first half of 2020.

    Balance Sheet Highlights

    As of June 30, 2021, MediWound had $17.2 million in cash and short-term investments, compared with $21.6 million as of December 31, 2020, and no debt. MediWound remained on budget, utilizing $4.4 million in the first half of 2021 for its operational activities. Throughout the remainder of 2021, the company will continue to invest primarily in research and development efforts for EscharEx, while the planned NexoBrid BLA resubmission and its related ongoing development programs will be funded by BARDA. We now expect cash use for 2021 to be in the range of $9.0 to $11.0 million.

    Conference Call

    MediWound management will host a conference call for investors today, Thursday, August 10, 2021, beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.) 1 809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3782335. The call also will be webcast live on the Company's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be available on the Company website for 90 days at www.mediwound.com.

    Non-IFRS Financial Measures

    To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.

    Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.

    However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; timing or likelihood of approval by the U.S. Food & Drug Administration (FDA) of a Biologics License Application (BLA) for NexoBrid for treatment of severe burns in the United States following the receipt of a complete response for NexoBrid on June 28, 2021, the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA, including availability of funding from BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic on our business or the economy generally.

    For example, we are unable to predict how the COVID-19 pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and may impact the response times of governmental agencies, including the FDA, to future regulatory submissions and/or conduct necessary reviews or inspections of our manufacturing facilities, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of our products, including NexoBrid. Other disruptions or potential disruptions of the COVID-19 pandemic include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts or initiatives that may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.



    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

    Jeremy Feffer

    Managing Director

    LifeSci Advisors 

    212-915-2568

    jeremy@lifesciadvisors.com

    MediWound, Ltd.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands

      June 30, December 31,
      2021 2020 2020
      Un-audited Audited
    Cash, cash equivalents and short term deposits 17,175 24,382 21,584
    Accounts and other receivable 2,948 3,492 3,229
    Inventories 1,397 1,934 1,380
    Total current assets 21,520 29,808 26,193
           
    Property, plant and equipment, net 2,565 2,326 2,630
    Right of use assets, net 1,789 2,086 1,884
    Intangible assets, net 330 396 363
    Total long-term assets 4,684 4,808 4,877
           
    Total assets 26,204 34,616 31,070
           
    Current maturities of long-term liabilities 1,681 1,321 1,750
    Trade payables and accrued expenses 4,060 2,423 2,992
    Other payables 3,920 6,040 3,524
    Total current liabilities 9,661 9,784 8,266
           
    Deferred revenues 405 1,174 1,234
    Liability in respect of Israeli Innovation Authority grants net of current maturity 7,671 7,130 7,267
    Liabilities in respect of purchase of shares net of current maturity 4,465 4,249 4,998
    Lease liability, net of current maturity 1,604 1,866 1,741
    Severance pay liability, net 280 281 292
    Total long-term liabilities 14,425 14,700 15,532
           
    Shareholders' equity 2,118 10,132 7,272
    Total liabilities & shareholder equity 26,204 34,616 31,070

    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS) (ANAUDITED)

    U.S. dollars in thousands

     Six months ended Three months ended
    June 30, June 30,
     2021  2020  2021  2020 
            
    Revenues11,904 8,465 6,057 4,027
    Cost of revenues7,127 6,018 3,696 2,810
    Gross profit 4,777 2,447 2,361 1,217
            
    Operating expenses:       
    Research and development4,898 3,331 2,656 1,612
    Selling, general & administrative4,695 4,028 2,600 2,311
    Operating loss(4,816) (4,912) (2,895) (2,706)
            
    Financial expenses, net(1,211) (645) (281) (390)
    Loss before tax on income(6,027) (5,557) (3,176) (3,096)
            
    Tax on income(19) - (19) -
    Loss for the period(6,046) (5,557) (3,195) (3,096)
    Foreign currency translation adjustments8 1 (3) (7)
    Total comprehensive loss(6,038) (5,556) (3,198) (3,103)
            
    Net loss per share(0.22) (0.20) (0.12) (0.11)
    Weighted average number of

    ordinary shares used in the

    computation of basic and diluted

    loss per share:
    27,241 27,207 27,211 27,052

    MediWound, Ltd.

    ADJUSTED EBITDA

    U.S. dollars in thousands

     Six months ended Three months ended
     June 30, June 30,
     2021  2020  2021  2020 
    Loss for the period(6,046) (5,557) (3,195) (3,096)
            
    Adjustments:       
    Financial expenses, net(1,211) (645) (281) (390)
    Tax on income(19) - (19) -
    Depreciation and amortization(627) (539) (354) (271)
    Share-based compensation expenses(884) (519) (500) (346)
    Total adjustments(2,741) (1,703) (1,154) (1,007)
    Adjusted EBITDA (3,305) (3,854) (2,041) (2,089)

    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)

    U.S. dollars in thousands

      Six months ended Three months

    ended
      June 30, June 30,
      2021 2020 2021 2020
    Cash Flows from Operating Activities:        
    Net loss (6,046) (5,557) (3,195) (3,096)
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Adjustments to profit and loss items:        
    Depreciation and amortization 627 539 319 271
    Share-based compensation 884 519 500 346
    Revaluation of liabilities in respect of IIA grants 497 424 222 226
    Revaluation of liabilities in respect of purchase of shares 299 348 147 196
    Revaluation of lease liabilities 35 64 79 100
    Increase (decrease) in severance liability, net (5) 40 5 19
    Financing income, net (11) (191) - (81)
    Unrealized foreign currency (gain) loss (226) 28 (482) (51)
      2,100 1,771 790 1,026
    Changes in asset and liability items:        
    Increase in trade receivables 680 1,341 3,087 444
    Decrease (increase) in inventories 17 (326) 62 65
    Increase in other receivables (432) (284) (469) (383)
    Increase (decrease) in trade payables and prepaid expenses 1,075 (1,649) 803 (1,004)
    Increase in other payables & deferred revenues (1,257) 86 (2,063) 133
      83 (832) 1,420 (745)
    Net cash used in operating activities (3,863) (4,618) (985) (2,815)
             
    Cash Flows from Investment Activities:        
    Purchase of property and equipment (244) (244) (26) (100)
    Interest received 35 42 - 39
    Proceeds from short term bank deposits, net of investments 4,002 10,595 (4) 7,603
    Net cash provided by (used in) investing activities 3,793 10,393 (30) 7,542
     



            
    Cash Flows from Financing Activities:        
    Repayment of lease liabilities (337) (313) (171) (153)
    Proceeds from IIA grants, net of repayments (180) (66) - -
    Net cash used in financing activities (517) (379) (171) (153)
             
    Exchange rate differences on cash and cash equivalent balances 204 (26) 495 57
    Increase (decrease) in cash and cash equivalents from activities (383) 5,370 (691) 4,631
    Balance of cash and cash equivalents at the beginning of the period 17,376 7,242 17,684 7,981
    Balance of cash and cash equivalents at the end of the period 16,993 12,612 16,993 12,612

     



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  4. YAVNE, Israel, Aug. 02, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the second quarter ended June 30, 2021 at 7:00 am Eastern Time on Tuesday, August 10, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Tuesday, August 10, 2021 at 8:30 am Eastern Time to discuss the financial results, provide a corporate update and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details                 

    Toll-Free:877-602-7189
    Israel:1-809-315-362
    International:

    YAVNE, Israel, Aug. 02, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the second quarter ended June 30, 2021 at 7:00 am Eastern Time on Tuesday, August 10, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Tuesday, August 10, 2021 at 8:30 am Eastern Time to discuss the financial results, provide a corporate update and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details                 

    Toll-Free:877-602-7189
    Israel:1-809-315-362
    International:678-894-3057
    Conference ID:3782335
    Webcast:https://edge.media-server.com/mmc/p/f27uaqvy

    To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.  An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair. NexoBrid®, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Contacts: 
    Boaz Gur-Lavie 

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com 

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com 



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  5. Independent Data Monitoring Committee Recommends Continuation of the Study with
    No Changes to Study Sample Size

    No Safety Concerns Identified

    Full Study Enrollment Expected by Year-End 2021; Data Readout Expected in the First Half of 2022

    YAVNE, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control…

    Independent Data Monitoring Committee Recommends Continuation of the Study with

    No Changes to Study Sample Size

    No Safety Concerns Identified

    Full Study Enrollment Expected by Year-End 2021; Data Readout Expected in the First Half of 2022

    YAVNE, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

    Based on the Independent Data Monitoring Committee's (IDMC) recommendation, no changes to the original enrollment target of 120 patients is required to maintain the pre-specified statistical power of 80 percent or greater on the study's primary endpoint of incidence of complete debridement compared with gel vehicle. In addition, the IDMC reviewed the data of all subjects treated and no safety concerns were identified in the study population. The IDMC's recommendations were based on the results of a pre-specified interim conditional power assessment conducted after approximately two-thirds of the originally targeted of 120 patients completed the debridement treatment.

    "We are very pleased with the IDMC's recommendation to continue the EscharEx study as originally planned without modifying the study sample size," said Sharon Malka, Chief Executive Officer of MediWound. "This interim outcome suggests that EschareEx is safe and tolerable, and increases our confidence that EscharEx may prove to be an effective non-surgical therapy for debridement of chronic wounds. With a clear unmet medical need for a non-surgical rapid and effective debridement agent in the outpatient setting, EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. We remain on track to complete patient enrollment by year-end, with data readout expected in the first half of 2022."

    The multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs. The study is expected to enroll 120 patients at approximately 20 clinical sites, primarily in the U.S. Study participants are randomized to either EscharEx, placebo control or non-surgical standard-of-care of either enzymatic or autolytic debridement, at a ratio of 3:3:2, with a three-month follow-up. The study includes a pre-defined interim assessment for futility and potential sample size adjustment. The primary endpoint is incidence of complete debridement compared to gel vehicle placebo control. Secondary endpoints include time to achieve complete debridement, reduction of pain, reduction of wound area, granulation tissue and quality of life. Incidence and time to achieve wound closure will be assessed as safety measurements.

    About EscharEx

    EscharEx, our bioactive therapy for debridement of chronic and other hard-to-heal wounds, is a product candidate in advanced stages of clinical development. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy-to-use product candidate, for topical daily applications, which designed for the outpatient setting.

    In two phase 2 trials, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only few daily applications. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's Annual Report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com



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  6. Data Expected End of 2021

    Phase II Investigator-Initiated Trial in Non-Melanoma Skin Cancers Running in Parallel

    YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

    The phase I/II open-label, randomized clinical study is designed to…

    Data Expected End of 2021

    Phase II Investigator-Initiated Trial in Non-Melanoma Skin Cancers Running in Parallel

    YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

    The phase I/II open-label, randomized clinical study is designed to evaluate the safety and tolerability of MW005 in BCC using different schedules of administration, as well as to provide a preliminary evaluation of its efficacy, as measured by the percentage of target lesions with complete histological clearance. The study will enroll up to 32 patients with histologically confirmed superficial or nodular BCC and will be conducted at three leading clinical centers in the United States.

    The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MW005 in removing non-melanoma skin cancers and pre-cancerous lesions (e.g., actinic keratosis, BCC, and squamous cell carcinoma) in up to 50 patients.

    "Most low-risk BCCs are treated surgically. There is a clear unmet need for an effective, non-surgical, topically-applied, short duration treatment for low-risk BCC, with less severe local skin reactions associated with current topical therapies," said Dr. Brian Berman, past president of American Dermatological Association, Professor Emeritus, University of Miami, and a lead principal investigator of the phase I/II study. "We are pleased to lead the clinical evaluation of MW005 as a potentially impactful topical therapy for low-risk BCC, given its pro-apoptotic mechanism of action and preliminary proof-of-concept efficacy."

    "We are excited to initiate this U.S. phase I/II study of MW005, which is the first step in this important clinical development program. MW005 represents a meaningful progress in our strategy to leverage our innovative enzymatic technology platform to pioneer solutions for unmet medical needs," said Sharon Malka, Chief Executive Officer of MediWound. "We are encouraged by the interest expressed by the clinical community to participate in this study, and we look forward to working closely with practitioners and patients as we advance this program to potentially treat the most common form of human cancer."

    BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million cases diagnosed every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.

    About MW005

    MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development. MW005 is based on a proprietary formulation, designed to ease self-administration by the patients, and is based on the same active substance as in NexoBrid® and EscharEx®, a concentrate of proteolytic enzymes enriched in bromelain.

    The clinical development program of MW005 is supported by results from several toxicological and other preclinical studies, as well as the vast clinical experience with NexoBrid and EscharEx. In addition, a recently-published case series, wherein MW005 (a concentrate of proteolytic enzymes enriched in bromelain) was used for destruction of basal cell carcinoma, provides a preliminary clinical proof-of-concept that MW005 may be a safe and effective treatment in this indication.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burns, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including MW005. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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  7. YAVNE, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced positive topline results from its pivotal phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study) with NexoBrid® to treat children with severe thermal burns, evaluating the efficacy and safety compared with standard-of-care (SOC).

    The study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in time to achieve complete eschar removal and significant reduction in wound area requiring surgical excision (surgical need…

    YAVNE, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced positive topline results from its pivotal phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study) with NexoBrid® to treat children with severe thermal burns, evaluating the efficacy and safety compared with standard-of-care (SOC).

    The study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in time to achieve complete eschar removal and significant reduction in wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and reduction in need for autograft in deep partial burns, as well as a favorable trend in reduction of blood loss during the eschar removal process. In addition, the study showed that NexoBrid was safe and well-tolerated.

    "We are thrilled to see such robust results across all primary endpoints, which corroborate the positive results of our pivotal phase 3 clinical studies in adult patients, and clearly demonstrate the significant beneficial impact NexoBrid has on the lives of pediatric burn patients," said Sharon Malka, Chief Executive Officer of MediWound. "It is gratifying to know that NexoBrid, with these highly compelling top-line results, is one step closer to becoming available as a treatment option for pediatric patients with severe burns."

    Dr. Lior Rosenberg, MediWound's Chief Medical Technology Officer, added, "This study is one of the most comprehensive randomized controlled studies ever conducted in burn care generally and within the pediatric population specifically. We thank all the Principal Investigators and their teams, as well as the patients and their families, for their work and commitment to advance burn care. We also thank the U.S. Biomedical Advanced Research and Development Authority (BARDA) for their continued support for this project. The current mode of pediatric burn management requires intensive medical therapy, which poses challenges due to the surgical complexities in treating young patients with severe burns. Having NexoBrid as a non-surgical option provides a minimally invasive alternative to the current surgical standard of care for treating severe burns in pediatric patients."

    CIDS Study Design and Objectives

    The NexoBrid CIDS study is a multicenter, multinational, randomized, controlled, open label study, performed in children with deep partial thickness (DPT) and full thickness (FT) thermal burns. The study's objectives are to evaluate the efficacy and safety of treatment with NexoBrid compared with standard of care (SOC) in hospitalized children with severe thermal burns of 1 percent to 30 percent Total Body Surface Area (TBSA). The study enrolled 145 pediatric patients, from newborn to eighteen years of age, randomized to either NexoBrid or SOC at a ratio of 1:1, across 36 burn centers worldwide. Topline results include acute phase and twelve-month follow-up data analysis. The long-term follow-up for cosmesis and function, quality of life and safety measurements is ongoing, and data is expected in the first half of 2023.

    The European Medicines Agency ("EMA") endorsed the study design as part of the agreed-upon Pediatric Investigational Plan ("PIP") to support the indication label expansion to include pediatric patients. The primary endpoints included early eschar removal, reduction of wound area surgically excised (surgical need) and non-inferiority cosmesis and function at twelve months follow-up from wound closure. Secondary endpoints included reduction in the need for surgical excision for eschar removal (surgical need), blood loss, reduction of the need for autograft in DPT wounds and non-inferiority in cosmesis and function at twenty-four months follow-up from wound closure. Non-inferiority of the time to complete wound closure and other standard safety measurements were also compared with the SOC control arm.

    The study was expanded to include burn centers in the United States following agreement with the FDA, under the same protocol with alignment to the U.S. phase 3 study (DETECT) protocol for adult population. The non-inferiority of cosmesis and function at twelve months and twenty-four months from wound closure were defined as safety measurements. In addition, reduction in surgical need was measured only by reduction in incidence of surgical excision for eschar removal.

    Funding and support for this pivotal pediatric Phase 3 clinical study (CIDS) with NexoBrid is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the office of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing contract number HHSO100201500035C.

    Summary of Study Topline Results

    Demographics and other baseline characteristics

    The overall patient demographics and wound baseline characteristics were comparable across study arms.

    Primary Endpoints

    The study met its three primary endpoints with highly statistical significance. Patients treated with NexoBrid demonstrated a significantly shorter time to achieve complete eschar removal compared with patients treated with SOC (median time to complete eschar removal - NexoBrid: 0.99 days vs. SOC: 5.99 days, p=0.00081).

    Patients treated with NexoBrid demonstrated a significant reduction in surgical need for excisional eschar removal as measured by an analysis of percent wound area surgically excised for eschar removal. Patients treated with NexoBrid incurred a significantly lower percent of wound area surgically excised for eschar removal compared with patients treated with SOC (NexoBrid: 1.5% vs. SOC: 48.1%, p<0.0001).

    The non-inferiority analysis of cosmesis and function of scars (quality of scars) measured by MVSS (modified Vancouver scar scale) at twelve-months from wound closure, demonstrated that NexoBrid was non-inferior to SOC (p<0.0001).

    Secondary Endpoints

    The study included several secondary endpoints that provided further insight on additional efficacy parameters.

    Patients treated with NexoBrid demonstrated a statistically significant lower incidence of surgical excision for eschar removal compared with patients treated with SOC (NexoBrid: 8.33% (6/72) vs. SOC: 64.38% (47/73), p<0.0001).

    Patients treated with NexoBrid incurred lower blood loss during the eschar removal procedure compared with patients treated with SOC, demonstrating a clear trend in favor of NexoBrid (mean volume – NexoBrid: 32.36 ml vs. SOC: 202.55 ml, p=0.134).

    Patients treated with NexoBrid demonstrated significant reduction of incidence of autograft performed in DPT wounds (on a target wounds level analysis) compared with patients treated with SOC (NexoBrid: 25.93% (21/81) vs. SOC: 37.63% (26/69), p=0.05).

    Patients treated with NexoBrid incurred a numerically lower percent area of DPT wound autografted compared with patients treated with SOC (NexoBrid: 15.9% vs. SOC: 22.8%, p=0.5).

    Safety

    No deleterious effect on wound healing was observed. Patients treated with NexoBrid had a non-inferior time to complete wound closure compared with patients treated with SOC (p=0.01491). Estimated median time to complete wound closure, using Kaplan Meier analysis, was 32 days for patients treated with NexoBrid and 34 days for patients treated with SOC.

    The study DSMB (Data Safety Monitoring Board) reviewed the data of all subjects and found NexoBrid to

    be safe and well tolerated. No safety concerns were identified in the study population.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month and twenty- four-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. NexoBrid is currently an investigational product in the United States.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA. Funding and technical support for development of NexoBrid to obtain marketing approval in the U.S. including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's Annual Report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com
    Jeremy Feffer

    Managing Director

    LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com 

    1 Generalized Wilcoxon-Gehan test



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  8. Study Findings Demonstrate Strong Results in Debriding Venous Leg Ulcers and Diabetic Foot Ulcers

    Interim Assessment of Ongoing U.S. Phase II Adaptive Design Study in Venus Leg Ulcers Expected End of July 2021

    YAVNE, Israel, July 09, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication, detailing the results of a phase 2 randomized control trial of its wound debriding product candidate EscharEx®, has been published in the Wound Repair and Regeneration Journal. An interim assessment of EscharEx's U.S. phase 2 adaptive design study for the treatment of venous…

    Study Findings Demonstrate Strong Results in Debriding Venous Leg Ulcers and Diabetic Foot Ulcers

    Interim Assessment of Ongoing U.S. Phase II Adaptive Design Study in Venus Leg Ulcers Expected End of July 2021

    YAVNE, Israel, July 09, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication, detailing the results of a phase 2 randomized control trial of its wound debriding product candidate EscharEx®, has been published in the Wound Repair and Regeneration Journal. An interim assessment of EscharEx's U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) is expected by end of July 2021.

    The paper, entitled Bromelain-based enzymatic debridement of chronic wounds: Results of a multicenter randomized controlled trial,1 summarizes the results of a phase 2 assessor blinded study of EscharEx (first generation) for the debridement of chronic and hard-to-heal wounds. The study, conducted at 15 clinical sites in Israel and Europe, evaluated the safety and efficacy of EscharEx compared with a hydrogel vehicle in a variety of chronic and hard-to-heal wounds. Seventy-three patients suffering from lower extremity ulcers, such as diabetic foot ulcers (DFUs), venous legs ulcers (VLUs), and post-surgical or traumatic hard-to-heal wounds, were enrolled in this trial. Patients were randomized to topical treatment by either EscharEx or its gel vehicle for up to 10 daily 4-hour applications, and then continued follow-up for up to 6 months.

    The EscharEx arm achieved a significantly higher incidence of complete debridement compared to the gel vehicle arm, thus meeting the primary endpoint of this study. The EscharEx and gel vehicle arms achieved similar reductions in wound area, non-viable tissue area, and wound healing scores during the debridement period. There were no significant differences between the arms in the incidence of complete wound closure and in the mean time to complete wound closure, and no significant safety issues were observed.

    "We are very excited to have our phase 2 data published in this respected journal. The data clearly demonstrate that EscharEx debrides severe wounds rapidly and effectively with no deleterious effect on wound healing," said Sharon Malka, Chief Executive Officer of MediWound. "We believe EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. We also look forward to the interim assessment of our U.S Phase 2 adaptive design study in venous leg ulcers as we continue to advance EscharEx's clinical development program."

    About EscharEx

    EscharEx, our bioactive therapy for debridement of chronic and other hard-to-heal wounds, is a product candidate in advanced stages of clinical development. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy-to-use product candidate, for topical daily applications, which designed for the outpatient setting.

    In two phase 2 trials, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only few daily applications. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair. NexoBrid®, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of pre-clinical and clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts: 
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com

    1 Bromelain‐based enzymatic debridement of chronic wounds: Results of a multicentre randomized controlled trial - Shoham - - Wound Repair and Regeneration - Wiley Online Library 



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  9. YAVNE, Israel, June 29, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

    The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls…

    YAVNE, Israel, June 29, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

    The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls ("CMC") section of the BLA and requested additional CMC information. The FDA acknowledged receipt of several CMC amendments, submitted in response the CMC information requests, which were not reviewed for this action.

    The FDA also stated that an inspection of NexoBrid's manufacturing facilities in Israel and Taiwan, are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to COVID-related travel restrictions. The FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), and requested the company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study. The FDA also requested to provide a safety update as part of its BLA resubmission, although there were no safety issues raised in the CRL.

    "While we are disappointed that the FDA has issued a CRL for NexoBrid, we remain confident in the strength of our clinical data and in the depth of our development program," said Sharon Malka, Chief Executive Officer of MediWound. "We remain committed to working collaboratively with the Agency, as well as BARDA, to identify the most expeditious pathway toward a potential approval for this important therapy. We believe that, upon approval, NexoBrid will benefit severe burn victims in routine care and serve as a critical medical countermeasure in case of a U.S. mass casualty incident."

    NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA), including the ongoing expanded access protocol (NEXT) in the U.S., which allows for the continued clinical use of NexoBrid during FDA's review of the NexoBrid BLA. In addition, BARDA procured NexoBrid for the U.S. emergency stockpile as part of its mission to build national preparedness for public health emergencies.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month and twenty four-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. NexoBrid is currently an investigational product in the United States.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA. Funding and technical support for development of NexoBrid to obtain marketing approval in the U.S. including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's Annual Report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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  10. YAVNE, Israel, June 09, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the enrollment target of patients for an interim assessment of its EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) has been achieved, and interim assessment is expected by the end of July 2021. The pre-defined interim assessment is for futility analysis and potential sample size adjustment. This study, which is targeted to enroll a total of 120 patients by year-end 2021, is designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control…

    YAVNE, Israel, June 09, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the enrollment target of patients for an interim assessment of its EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) has been achieved, and interim assessment is expected by the end of July 2021. The pre-defined interim assessment is for futility analysis and potential sample size adjustment. This study, which is targeted to enroll a total of 120 patients by year-end 2021, is designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

    "We are very pleased to reach this important clinical milestone, and we look forward to the interim assessment next month," said Sharon Malka, Chief Executive Officer of MediWound. "With a clear unmet medical need for a non-surgical rapid and effective debridement agent in the outpatient setting, EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. EscharEx represents a significant market opportunity for MediWound, with an addressable market of over a billion dollars annually."

    As part of the Company's broader EscharEx development program, MediWound is also conducting a phase 2 open-label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers (DFUs) and VLUs. The objective of this study is to gain a better understanding of what is happening in the wound bed, both during and after debridement with EscharEx, and to assess its effect on biofilm burden, reduction in inflammation, and the initiation of wound healing. MediWound expects to generate data from this study in the second half of 2021.

    About EscharEx

    EscharEx, our bioactive therapy for debridement of chronic and other hard-to-heal wounds, is a product candidate in advanced stages of clinical development. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy-to-use product candidate, for topical daily applications, which designed for the outpatient setting.

    In two phase 2 trials, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only few daily applications. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair.

    NexoBrid®, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of pre-clinical and clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

                          Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com
       


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  11. Findings Provide Preliminary Proof-of-Concept

    Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin in Second Quarter 2021, with Data Expected by the End of 2021

    YAVNE, Israel, June 07, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication of a case series report of basal cell carcinoma (BCC) destruction by a concentrate of proteolytic enzymes enriched in bromelain has been published in the Open Dermatology Journal. MediWound anticipates initiating a phase I/II clinical study of MW005 for the treatment of BCC this month, with…

    Findings Provide Preliminary Proof-of-Concept

    Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin in Second Quarter 2021, with Data Expected by the End of 2021

    YAVNE, Israel, June 07, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication of a case series report of basal cell carcinoma (BCC) destruction by a concentrate of proteolytic enzymes enriched in bromelain has been published in the Open Dermatology Journal. MediWound anticipates initiating a phase I/II clinical study of MW005 for the treatment of BCC this month, with data expected by the end of 2021.

    The paper, entitled Basal Cell Carcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report (opendermatologyjournal.com), details case series experience using a concentrate of proteolytic enzymes enriched in bromelain for the destruction of six BCC tumors. Six BCCs located on the face, neck, and extremities were self-treated by three patients with 2-6 applications. All of the BCCs were completely removed and two of the lesion's sites were surgically excised after 6 months with no tumor cells noted on histopathology. None of the BCCs recurred over the subsequent year. The findings provide a preliminary proof-of-concept that a concentrate of proteolytic enzymes enriched in bromelain may be a safe and effective destructive treatment for basal cell carcinomas.

    "We are very excited to have our case series data published in a peer reviewed paper," said Prof. Lior Rosenberg, Chief Medical Technology Officer of MediWound. "The data provide a preliminary evaluation of MW005 efficacy as a destructive treatment for BCC, which we plan to further evaluate in our planned clinical studies. These clinical experiences, combined with our pre-clinical in-vitro research and existing scientific evidence, suggest that MW005 might have a role in treating low-risk non-melanoma skin malignancies."

    "Non-melanoma skin cancers are by far the most common of all types of cancer and represent a significant potential market opportunity," said Sharon Malka, Chief Executive Officer of MediWound. "We are pleased with the positive data, which establish the foundation for our non-melanoma skin cancer clinical development plan. We believe that MW005 has a reasonable path to market with a clear unmet medical need, and the clinical plan we have laid out carries relatively low development costs given its active substance which has wealth of pre-clinical and clinical data and the intended indication."

    BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million diagnosed cases every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.

    About MW005

    MW005, is a topically applied biological product candidate based on the same active substance as in NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in bromelain. MW005 is based on a proprietary formulation, designed to ease self-administration by the patients. The clinical development plan of MW005 is supported by results from several toxicological and other preclinical studies, as well as the vast clinical experience from NexoBrid and EscharEx, which share the same active substance.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. MediWound's third innovative product candidate, MW005, is a topical drug under development for the treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including MW005. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com



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  12. First Quarter Revenues of $5.8 Million, an Increase of 32% Year-over-Year

    Conference call begins today at 8:30 am ET

    YAVNE, Israel, May 05, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced financial results for the first quarter ended March 31, 2021.

    First Quarter and recent weeks Financial and Business Highlights:

    • Total revenues for the first quarter of 2021 were $5.8 million, an increase of 32% compared with the first quarter of 2020, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA)
    • Cash and short-term investments…

    First Quarter Revenues of $5.8 Million, an Increase of 32% Year-over-Year

    Conference call begins today at 8:30 am ET

    YAVNE, Israel, May 05, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced financial results for the first quarter ended March 31, 2021.

    First Quarter and recent weeks Financial and Business Highlights:

    • Total revenues for the first quarter of 2021 were $5.8 million, an increase of 32% compared with the first quarter of 2020, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA)
    • Cash and short-term investments of $17.9 million as of March 31, 2021, compared with $21.6 million as of December 31, 2020
    • Hosted an Analyst Day on March 30 highlighting EscharEx® as an enzymatic debridement agent for chronic wounds featuring presentations by key opinion leaders.
    • Enrolled the first patient in phase 2 pharmacology study of EscharEx, with data expected in the second half of 2021
    • Submitted a protocol to the U.S. Food and Drug Administration (FDA) for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma; study initiation is planned for the second quarter of 2021
    • Received marketing approval for NexoBrid in Chile and the Republic of China (Taiwan) and continue global expansion strategy with new distribution agreements in Europe and Asia

    "This quarter was one of continued progress across the board, highlighted by the continued revenue growth and NexoBrid global expansion, the enrollment of the first patient in our phase 2 pharmacology study of EscharEx, and the initiation of a new clinical program in non-melanoma skin cancer," said Sharon Malka, Chief Executive Officer of MediWound. "We were proud to host an analyst day webinar in March on EscharEx, featuring four prominent key opinion leaders who discussed the current U.S. wound debridement practices and how EscharEx, upon approval, has the potential to change current standard of practice and care of chronic wounds. We continue to advance our U.S. phase 2 adaptive design study of EscharEx for the treatment of venous leg ulcers and look forward to an interim assessment later this year. Finally, we remain focused on continuing to drive revenue growth and further strengthen our company."

    First Quarter Financial Results

    Revenues for the first quarter of 2021 were $5.8 million, compared with $4.4 million for the first quarter of 2020, an increase of 32%. Revenues from products and licenses in the first quarter of 2021 were $2.9 million, an increase of 300% compared to the first quarter of 2020, primarily driven by the procurement of NexoBrid by BARDA for emergency response preparedness and sales increase outside the U.S.

    Gross profit for the first quarter of 2021 was $2.4 million, or 41% of net revenues, compared to a gross profit of $1.2 million, or 28% of net revenues for the first quarter of 2020.

    Research and development expenses for the first quarter of 2021, were $2.2 million, compared with $1.7 million for the first quarter of 2020. The increase was a result of EscharEx clinical development program.

    Selling, general and administrative expenses for the first quarter of 2021 were $2.1 million, compared with $1.7 million in the first quarter of 2020 as a result of directors and officer's insurance cost increase. As a percentage of revenues, selling, general and administrative expenses for the first quarter decreased from 39% in the first quarter of 2020 to 36% for the first quarter of 2021.

    Operating loss for the first quarter of 2021 was $1.9 million, reflecting a 13% decrease in operating loss compared to the $2.2 million in the first quarter of 2020.

    The Company posted a net loss of $2.9 million, or $0.10 per share, for the first quarter of 2021 compared with a net loss of $2.5 million, or $0.09 per share, for the first quarter of 2020.

    Adjusted EBITDA, as defined below, for the first quarter of 2021 was a loss of $1.3 million, compared with a loss of $1.8 million for the first quarter of 2020, reflecting a decrease in adjusted EBIDTA loss of 28%.

    Balance Sheet Highlights

    As of March 31, 2021, MediWound had $17.9 million in cash and short-term investments, compared with $21.6 million as of December 31, 2020, and no debt. MediWound remained on budget, utilizing $3.7 million in the first quarter of 2021 for its operational activities. The Company expects cash use for 2021 to be in the range of $5.0 to $7.0 million.

    Conference Call

    MediWound management will host a conference call for investors today, Wednesday, May 5, 2021 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.) 1 809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3496059. The call also will be webcast live on the Company's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be available on the Company website for 90 days at www.mediwound.com.

    Non-IFRS Financial Measures

    To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.

    Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.

    However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. MediWound's third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    About BARDA

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States and readiness for emergencies. For more information, refer to www.phe.gov/about/BARDA.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts: Jeremy Feffer
    Boaz Gur-Lavie  Managing Director
    Chief Financial Officer LifeSci Advisors
    MediWound Ltd.  212-915-2568
    ir@mediwound.com jeremy@lifesciadvisors.com





    MediWound, Ltd.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands

     March 31,  December 31, 
      2021   2020   2020 
     Un-audited  Audited 
    Cash, cash equivalents and short term deposits 17,862   27,311   21,584 
    Accounts and other receivable 5,574   3,540   3,229 
    Inventories 1,470   2,004   1,380 
    Total current assets 24,906   32,855   26,193 
                
    Property, plant and equipment, net 2,694   2,339   2,630 
    Right of use assets, net 1,747   2,191   1,884 
    Intangible assets, net 347   413   363 
    Total long term assets 4,788   4,943   4,877 
                
    Total assets 29,694   37,798   31,070 
                
    Current maturities of long-term liabilities 1,884   1,417   1,750 
    Trade payables and accrued expenses 3,258   3,423   2,992 
    Other payables 5,172   5,843   3,524 
    Total current liabilities 10,314   10,683   8,266 
                
    Deferred revenues 693   1,018   1,234 
    Liabilities in respect of Israeli Innovation Authority grants net of current maturities 7,275   6,942   7,267 
    Liabilities in respect of purchase of shares net of current maturities 4,733   4,097   4,998 
    Lease liabilities, net of current maturities 1,590   1,905   1,741 
    Severance pay liability, net 273   264   292 
    Total long term liabilities 14,564   14,226   15,532 
                
    Shareholders' equity 4,816   12,889   7,272 
    Total liabilities & shareholder equity 29,694   37,798   31,070 





    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)

    U.S. dollars in thousands

     Three months ended

    March 31,

      2021   2020 
         
    Revenues 5,847   4,438 
    Cost of revenues 3,431   3,208 
    Gross profit 2,416   1,230 
    Operating expenses:    
    Research and development 2,242   1,719 
    Selling, general and administrative 2,095   1,717 
    Operating loss (1,921)  (2,206)
    Financial income 11   239 
    Financial expense (941)  (494)
    Loss for the period (2,851)  (2,461)
         
    Foreign currency translation adjustments 11   8 
    Total comprehensive loss (2,840)  (2,453)
         
    Basic and diluted loss per share:    
    Net loss per share (0.10)  (0.09)
    Weighted average number of ordinary shares used in the computation of basic and diluted loss per share: 27,237   27,211 





    ADJUSTED EBITDA

    U.S. dollars in thousands

     Three months ended
     March 31,
      2021   2020 
    Loss for the period (2,851)  (2,461)
    Adjustments:   
    Financial expenses, net (930)  (255)
    Depreciation and amortization (273)  (268)
    Share-based compensation expenses (384)  (173)
    Total adjustments (1,587)  (696)
    Adjusted EBITDA  (1,264)  (1,765)





    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW (UNAUDITED)

    U.S. dollars in thousands

     Three months ended
    March 31,
      2021   2020 
    Cash Flows from Operating Activities:   
    Net loss (2,851)  (2,461)
        
    Adjustments to reconcile net loss to net cash provided by (used in) operating activities:   
    Adjustments to profit and loss items:   
    Depreciation and amortization 273   268 
    Share-based compensation 384   173 
    Revaluation of liabilities in respect of IIA grants 275   198 
    Revaluation of liabilities in respect of purchase of shares 152   152 
    Revaluation of lease liabilities (44)  (36)
    Increase (decrease) in severance liability, net (10)  21 
    Financing income (11)  (110)
    Unrealized foreign currency (gain) loss 256   79 
      1,275   745 
    Changes in asset and liability items:   
    Decrease (increase) in trade receivables (2,407)  897 
    Increase in inventories (45)  (391)
    Decrease in other receivables 37   99 
    Increase (decrease) in trade payables & accrued expenses 272   (645)
    Increase (decrease) in other payables & deferred revenues 806   (47)
      (1,337)  (87)
    Net cash used in operating activities (2,913)  (1,803)
        
    Cash Flows from Investment Activities:   
    Purchase of property and equipment (218)  (144)
    Interest received 35   3 
    Proceeds from short term bank deposits, net of investments 4,006   2,992 
    Net cash provided by investing activities 3,823   2,851 
    Cash Flows from Financing Activities:   
    Repayment of lease liabilities (131)  (160)
    Repayment of IIA grants (180)  (66)
    Net cash used in financing activities (311)  (226)
        
    Exchange rate differences on cash and cash equivalent balances (291)  (83)
    Increase in cash and cash equivalents 308   739 
    Balance of cash and cash equivalents at the beginning of the period 17,376   7,242 
    Balance of cash and cash equivalents at the end of the period 17,684   7,981 

     



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  13. YAVNE, Israel, April 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the first quarter ended March 31, 2021 at 7:00 am Eastern Time on Wednesday, May 5, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Wednesday, May 5, 2021 at 8:30 am Eastern Time to discuss the financial results and provide corporate update, and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details
    Toll-Free:877-602-7189
    Israel Toll-Free:1 809 315 362
    International:678-894-3057

    YAVNE, Israel, April 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the first quarter ended March 31, 2021 at 7:00 am Eastern Time on Wednesday, May 5, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Wednesday, May 5, 2021 at 8:30 am Eastern Time to discuss the financial results and provide corporate update, and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details
    Toll-Free:877-602-7189
    Israel Toll-Free:1 809 315 362
    International:678-894-3057
    Conference ID:3496059
    Webcast:https://edge.media-server.com/mmc/p/7zehu5pu
      

    To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx®, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MediWound's third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Contacts: 
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com



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  14. YAVNE, Israel, April 22, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it has enrolled the first patient in its phase 2 pharmacology study of EscharEx®, its next-generation enzymatic debridement agent under development for chronic wounds, with data expected in the second half of 2021.

    The pharmacology study, to be conducted in 2-3 U.S. clinical sites, is a phase 2 prospective, open label, single arm study. The objective of the study is to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in debridement of lower leg ulcers (venous leg ulcers and diabetic…

    YAVNE, Israel, April 22, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it has enrolled the first patient in its phase 2 pharmacology study of EscharEx®, its next-generation enzymatic debridement agent under development for chronic wounds, with data expected in the second half of 2021.

    The pharmacology study, to be conducted in 2-3 U.S. clinical sites, is a phase 2 prospective, open label, single arm study. The objective of the study is to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in debridement of lower leg ulcers (venous leg ulcers and diabetic foot ulcers) in up to 15 patients. Data collection includes the effects on biofilm burden and wound inflammation, as well as the impact of EscharEx on wound healing progression.

    "Chronic wounds represent a significant unmet medical need for many patients, and EscharEx, with its positive safety and efficacy results generated in our previous phase 2 studies, can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers," said Sharon Malka, Chief Executive Officer of MediWound. "We anticipate data from the pharmacology study in the second half of this year, in addition to the interim assessment in our EscharEx phase 2 adaptive design study."

    "There is wide consensus among clinicians that infection and microbial biofilm impedes the healing process and prolongs wound healing. The treatment of biofilm in chronic wounds is rapidly becoming a primary objective of wound care," said Dr. Robert Snyder, Chief Medical Director of EscharEx program. "EscharEx may convert a chronic wound into one that is acute while also disrupting biofilm and planktonic bacteria, which could delay wound healing."

    About EscharEx



    EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleaves and removes the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About Biofilm1

    Biofilm is created through the attachment of bacteria to elements in the extracellular polymeric substances (EPS). The EPS, which is 50% to 90% of the total biofilm organic matter, is comprised of dead host tissue, microorganisms' secretions, proteins, nucleic acids, lipids, and polysaccharides. Biofilms have been reported to interfere with normal wound healing, apparently by ‘locking' the wound bed into a chronic inflammatory state that leads to elevated levels of tissue-degrading proteases and reactive oxygen species which damage cells and molecules needed for healing. A large percentage of bacteria in biofilm communities are metabolically dormant, and low metabolic rates make antibiotics ineffective. The EPS substances and their interactions are targets for therapeutic biofilm elimination.

    Bacterial biofilms have been shown to prolong the inflammatory process, which is detrimental to wound healing because of the degradation of the growth factors required for cellular proliferation and migration necessary for wound healing.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.



    NexoBrid, our first commercialized product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a BLA was submitted to the FDA and was assigned a PDUFA target date of June 29, 2021. NexoBrid is supported by BARDA.

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MediWound's third innovative product candidate, MWPC005, is a topical drug candidate under development for the treatment of non-melanoma skin cancer.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.



    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.



    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com

    ____________________________

    1 Source: World Union of Wound Healing Societies (WUWHS), Florence Congress, Position Document. Management of Biofilm. Wounds International 2016



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  15. YAVNE, Israel, March 24, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that it will host an analyst day webinar on EscharEx®, MediWound's enzymatic debridement agent for chronic wounds, on Tuesday, March 30, 2021 at 10am Eastern Time.

    The webinar will feature presentations by key opinion leaders (KOLs) Robert S. Kirsner, M.D., Ph.D., University of Miami; Adam J. Singer, M.D., Stony Brook University; and Robert J. Snyder, D.P.M., M.Sc., Barry University. The KOLs will discuss the current U.S. chronic wound debridement practices and how EscharEx, upon approval, has the potential to change…

    YAVNE, Israel, March 24, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that it will host an analyst day webinar on EscharEx®, MediWound's enzymatic debridement agent for chronic wounds, on Tuesday, March 30, 2021 at 10am Eastern Time.

    The webinar will feature presentations by key opinion leaders (KOLs) Robert S. Kirsner, M.D., Ph.D., University of Miami; Adam J. Singer, M.D., Stony Brook University; and Robert J. Snyder, D.P.M., M.Sc., Barry University. The KOLs will discuss the current U.S. chronic wound debridement practices and how EscharEx, upon approval, has the potential to change the current standard of practice and care of chronic wounds, recent in vivo head-to-head comparator study results and the biofilm opportunity. Additionally, Ilina Sen, Life Sciences Sr. Director, Huron Consulting Group, will discuss the U.S. market research insight. Drs. Kirsner, Singer, and Snyder, and Ms. Sen will be available for a Q&A session following their formal presentations. Sharon Malka, MediWound's Chief Executive Officer, will provide a corporate update and an overview of the EscharEx development program.

    EscharEx is MediWound's next-generation bioactive topical therapeutic under development, for debridement of chronic and hard to heal wounds. EscharEx active ingredient (API) is a concentrate of proteolytic enzymes enriched in bromelain. In two Phase 2 studies, EscharEx was well-tolerated and showed significantly higher incidence of complete debridement of various chronic wounds and other hard-to-heal wounds compared with hydrogel vehicle within a few daily applications as well as comparable safety profile. EscharEx is an investigational product, currently under investigation in a U.S. phase 2 adaptive design study.

    To register for the webinar, please click here.

    Dr. Kirsner is Chairman and the endowed Harvey Blank Professor in the Dr. Phillip Frost Dermatology in the Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine. He is Chief of Dermatology at the University of Miami Hospital and Clinics and Jackson Memorial Hospital and directs the University of Miami Hospital Wound Center. Dr. Kirsner received his undergraduate degree from Texas A&M University, his medical degree from the University of Miami and a PhD in epidemiology from the University of Miami, after he completed his clinical training. His clinical training included internal medicine, a clinical and research fellowship in wound healing and dermatology at the University of Miami. His research interests include Wound Healing and Skin Cancer Epidemiology. Dr. Kirsner serves as academic editor of the journal Wound Repair and Regeneration and is on the editorial boards for a number of journals in dermatology and wound healing. He also serves in national leadership positions in both Wound Healing and Dermatology, including currently serving on the American Academy of Dermatology Board of Directors and the Wound Healing Society Board of Directors. In addition to career development awards, foundation, industry sponsored funding and CDC funding, he currently leads or is part of a number of NIH funded grants. Independent of books, book chapters and abstracts, he has published over 550 articles.

    Dr. Adam Singer is a Professor of Emergency Medicine and Vice Chairman for Research in the Department of Emergency Medicine at Stony Brook University. Dr. Singer is a world renown expert in wound care. He has extensive preclinical and clinical experience in burn and wound care. He has over 400 publications, many in high impact journals such as the New England Journal of Medicine and JAMA, including a recent review article on lower extremity ulcers in the NEJM. He has received millions of dollars in extramural funding from the NIH, DOD, BARDA and industry. He is on the editorial board of multiple journals and is the Editor-in-Chief of Clinical and Experimental Emergency Medicine. He has considerable experience with both NexoBrid and EscharEx in both humans and animal models. His preclinical data in the porcine model helped support the EMA approval of NexoBrid and he has studied the use of EscharEx in several animal models. He has been a PI for all studies of bromelain-based enzymatic debridement of burns and ulcers in the US. He has also served on several national and international organizations and committees related to wound care.

    Dr. Robert Snyder is Professor and Director of Clinical Research and Fellowship Director in Wound Care and Research at Barry University School of Podiatric Medicine. He is certified in foot and ankle surgery by the American Board of Podiatric Surgery and is also a board certified wound specialist. Dr Snyder is past-president of the Association for the Advancement of Wound Care and past-president of the American Board of Wound Management, the certifying body for Wound Care Specialists. In addition to his doctorate, he holds an MSc in Wound Healing and Tissue Science from Cardiff University School of Medicine. His expertise at Cardiff, Wales, was further acknowledged by appointment as Honorary Senior Lecturer. To constantly expand his knowledge and stay current in all aspects of healthcare, he has completed an MBA in Health Management. Dr. Snyder is a key opinion leader and sought after speaker, lecturing extensively throughout the United States and abroad. He has been recognized with many awards for his contribution to the profession. Dr. Snyder has published several book chapters and over 165 papers in peer reviewed and trade journals on wound care. He serves as Associate Editor for JAPMA and is on the editorial advisory boards of Wound Management & Prevention, Wounds and Podiatry Management. He is also a periodic reviewer for the Lancet and NEJM. He has been a Principal Investigator on more than 50 randomized controlled trials for innovative wound healing modalities and therapies. In 2018, Dr. Snyder was inducted as a Faculty Fellow of the Royal College of Physicians & Surgeons (Glasgow).

    Ilina Sen brings 15 years of experience in life sciences strategy consulting. Ms. Sen guides leadership teams through research and development (R&D) portfolio planning, licensing, merger and acquisition opportunity identification, prioritization and valuation, and commercial and market access strategies for products throughout their life cycle. Her experience spans across therapeutic areas, with a focus in oncology, immune/inflammatory disorders, renal disorder, cardiovascular diseases and rare diseases. She has served a range of organizations, including top global biopharmaceutical companies, smaller biotech companies, and diagnostic firms.

    Prior to joining Huron, Ms. Sen worked as a life sciences strategy senior consultant at Frankel Group for eight years. She has also worked as a consultant at Quintiles Transnational in its strategic research services group. She began her career as a research associate at the National Cancer Institute. Ms. Sen received a M.S. in Biotechnology with a concentration in Regulatory Affairs from Johns Hopkins University​ and a B.S. in Biology with a minor in Biomedical Engineering from Carnegie Mellon University.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx®, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MediWound's third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment and the completion of enrollment, the time of commencing the pharmacological study and the results , the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid and EscharEx in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com 
    Jeremy Feffer

    Managing Director

    LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com 


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  16. YAVNE, Israel, Feb. 25, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will present at the following virtual investor conferences in March 2021:

    Cowen 41st Annual Health Care Conference
    Date:Tuesday, March 2
    Time:9:10 am ET
      
    Oppenheimer 31st Annual Healthcare Conference
    Date:   Tuesday, March 16
    Time: 1:10 pm ET

    A live webcast of each event will be available on the Events page of the Investors section of the Company's website: www.mediwound.com. A replay of each webcast will be available on the Company's website for approximately 30 days.

    About MediWound Ltd.

    MediWound…

    YAVNE, Israel, Feb. 25, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will present at the following virtual investor conferences in March 2021:

    Cowen 41st Annual Health Care Conference

    Date:Tuesday, March 2
    Time:9:10 am ET
      
    Oppenheimer 31st Annual Healthcare Conference

    Date:   Tuesday, March 16
    Time: 1:10 pm ET

    A live webcast of each event will be available on the Events page of the Investors section of the Company's website: www.mediwound.com. A replay of each webcast will be available on the Company's website for approximately 30 days.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx®, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MediWound's third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Contacts:   
    Boaz Gur-Lavie   Jeremy Feffer
    Chief Financial Officer               Managing Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.com    jeremy@lifesciadvisors.com 



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  17. Fourth Quarter Revenues of $6.7 Million - Up 23%
    and Full-Year 2020 Revenues of $21.8 Million - Product Revenue Up 117%

    Conference call begins today at 8:30 am ET

    YAVNE, Israel, Feb. 25, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced financial results for the fourth quarter and full-year ended December 31, 2020.

    Fourth Quarter and Full-Year 2020 Financial Highlights:

    • Total revenues of $21.8 million for the full year of 2020.

    • Total revenues of $6.7 million for the fourth quarter of 2020, an increase of 23% compared with $5.4 million for the fourth quarter of 2019, primarily driven by…

    Fourth Quarter Revenues of $6.7 Million - Up 23%

    and Full-Year 2020 Revenues of $21.8 Million - Product Revenue Up 117%

    Conference call begins today at 8:30 am ET

    YAVNE, Israel, Feb. 25, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced financial results for the fourth quarter and full-year ended December 31, 2020.

    Fourth Quarter and Full-Year 2020 Financial Highlights:

    • Total revenues of $21.8 million for the full year of 2020.



    • Total revenues of $6.7 million for the fourth quarter of 2020, an increase of 23% compared with $5.4 million for the fourth quarter of 2019, primarily driven by initiation of the Biomedical Advanced Research and Development Authority (BARDA) emergency stockpile procurement.



    • The company had $21.6 million in cash and short-term investments as of December 31, 2020.

    Fourth Quarter and Full-Year 2020 Business Highlights:

    • U.S. Food and Drug Administration (FDA) accepted for review the Company's Biologics License Application (BLA) for NexoBrid® and assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.



    • BARDA initiated the procurement of NexoBrid for emergency stockpile, valued at $16.5 million, with first deliveries accepted by BARDA in the third and fourth quarters of 2020, with additional deliveries planned through end of 2021.



    • Completed enrollment in the company's NexoBrid pivotal Phase 3 (CIDS) study; top-line data, including twelve-month follow-up safety data, are anticipated in the second half of 2021.



    • Completed U.S Phase 3 (DETECT) study, including patient long-term safety follow-up; the twenty-four-month safety data of cosmesis and function was comparable across all study arms with no new safety signals observed.



    • Continued NexoBrid global expansion with additional distribution agreements in France, Switzerland and other EU countries; entered the Middle Eastern market with the signing of a distribution agreement in the United Arab Emirates.



    • Adjusted the U.S. phase 2 adaptive design study of EscharEx® for the treatment of venous leg ulcers (VLUs) enrollment target to 120 patients down from the 174 originally planned; interim assessment is expected in mid-2021 and completion of enrollment by year-end 2021.



    • Launched a new clinical development program to evaluate its product candidate MWPC005 in patients with non-melanoma skin cancers; a U.S. phase I/II clinical study for the treatment of basal cell carcinoma (BCC) is scheduled to begin in the second quarter of 2021.

    "I am very proud of our team's perseverance and resilience in delivering positive results in our clinical programs and financial performance despite the enormous COVID-19 challenges that we all face globally. We look forward to 2021 as a pivotal year of important catalysts for MediWound," said Sharon Malka, Chief Executive Officer of MediWound. "We remain focused on our continued growth with the advancement of our EscharEx clinical program with a U.S phase 2 study interim assessment later this year. NexoBrid's global expansion continues as we look forward to NexoBrid's BLA approval in 2021. Finally, we are excited to initiate the clinical development program of MWPC005 as a treatment for BCC, leveraging our platform technology to enhance our diverse and innovative portfolio."

    Fourth Quarter Financial Results

    Revenues for the fourth quarter of 2020 were $6.7 million, compared with $5.4 million for the fourth quarter of 2019, an increase of 23%. Revenues from sale of product in the fourth quarter of 2020 were $2.8 million, reflecting an increase of 155% in comparison to the fourth quarter of 2019, primarily driven by BARDA emergency stockpile procurement.

    Gross profit for the fourth quarter of 2020 was $2.3 million and 35%, compared with a gross profit of $1.1 million and 20% for the fourth quarter of 2019. Gross margin from sale of products in the fourth quarter of 2020 was 56% in comparison to 32% for the fourth quarter of 2019.

    Research and development expenses for the fourth quarter of 2020, net of participations, were $2.2 million, compared with $1.7 million for the fourth quarter of 2019. The increase was primarily due to the ongoing EscharEx clinical development program.       

    Selling, general and administrative expenses for the fourth quarter of 2020 were $2.5 million, stable with the $2.4 million for the fourth quarter of 2019.

    Operating loss for the fourth quarter of 2020 was $2.4 million, compared with an operating loss of $3.1 million in the fourth quarter of 2019, primarily as a result of revenue growth.

    The Company posted a net loss of $1.7 million, or $0.06 per share, for the fourth quarter of 2020 compared with a net loss of $3.4 million, or $0.13 per share, for the fourth quarter of 2019.

    Adjusted EBITDA, as defined below, for the fourth quarter of 2020 was a loss of $1.8 million, compared with a loss of $2.4 million for the fourth quarter of 2019.

    Full Year 2020 Financial Results

    Revenues for the year ended December 31, 2020 were $21.8 million compared with $31.8 million for the year ended December 31, 2019, which included a $17.5 million upfront payment from the Vericel license agreement for NexoBrid. Revenues from product for the full year of 2020 were $7.8 million, an increase of 117% compared with the full year of 2019, primarily driven by BARDA emergency stockpile procurement.

    Gross profit for the year ended December 31, 2020 was $7.5 million, compared with a gross profit of $19.9 million in the prior year period. Excluding the $17.5 million upfront license payment net of $0.7 million of deal related expenses, gross profit for the year ended December 31, 2019, was $3.1 million. Gross margin from sale of products for the full year of 2020 was 60% in comparison to 35% for the full year of 2019.

    Research and development expenses for the year ended December 31, 2020, net of participations, were $7.7 million, compared with $5.0 million in the prior year period. The increase was primarily as a result of the U.S. Phase 2 adaptive design study of EscharEx and a non-cash increase in participation from the Israeli innovation authority grant recorded in 2019.

    Selling, general and administrative expenses for the year ended December 31, 2020 were $8.7 million compared with $9.3 million in the prior year period. The decrease was primarily due to the Company's headquarters' restructuring in Europe.

    Operating loss for the year ended December 31, 2020 was $8.8 million compared to an operating profit of $4.5 million for the year ended December 31,2019, which included $17.5 million upfront license payment and $1.7 million of NexoBrid licensing deal related expenses. Excluding the upfront license payment, net of deal related costs, operating loss for full year of 2019 was $11.3 million.

    The Company's net loss in 2020 was $9.2 million, or a loss of $0.34 per share, compared with a net profit of $5.0 million, or a profit of $0.18 per share for the same period in 2019, which included the $17.5 million upfront license payment and $1.7 million of NexoBrid licensing deal related expenses. Excluding the upfront license payment net of deal related costs, net loss for the year ended 2019 was $10.8 million, or $0.40 per share.

    Adjusted EBITDA, for the year ended December 31, 2020, was a loss of $6.4 million, compared with a profit of $8.0 million for the year ended December 31, 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of a royalty payment of $0.7 million.

    Balance Sheet Highlights

    The Company had $21.6 million in cash and short-term investments as of December 31, 2020, compared with $29.5 million as of December 31, 2019, with no debt. The Company utilized $7.9 million in cash to fund its ongoing operating activities and repayment of contingent liabilities during 2020, below its cash guidance for 2020 of $8.0 to $10.0 million. The Company expects cash use for 2021 to be in the range of $5.0 to $7.0 million. 

    Conference Call

    MediWound management will host a conference call for investors today, Thursday, February 25, 2021 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.) 1809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3049108. The call also will be webcast live on the Company's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be available on the Company website for 90 days at www.mediwound.com.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid, our first commercialized product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a BLA was submitted to the FDA and was assigned a PDUFA target date of June 29, 2021. NexoBrid is supported by BARDA.

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MediWound's third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    About BARDA

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States and readiness for emergencies. For more information, refer to www.phe.gov/about/BARDA.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future preclinical studies and clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

               Jeremy Feffer

    Managing Director

    LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com
       

    MediWound, Ltd.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    AUDITED

    U.S. dollars in thousands

      December 31,
      2020 2019
    Cash, cash equivalents and short term deposits 21,584 29,458
    Accounts and other receivable 3,229 4,557
    Inventories 1,380 1,613
    Total current assets 26,193 35,628
    Property, plant and equipment, net 2,630 2,304
    Right of-use assets, net 1,884 2,229
    Intangible assets, net 363 429
    Total long term assets 4,877 4,962
         
    Total assets 31,070 40,590
         
    Current maturities of long-term liabilities 1,750 569
    Trade payables and accrued expenses 2,992 4,067
    Other payables 3,524 5,737
    Total current liabilities 8,266 10,373
    Deferred revenues 1,234 1,135
    Liabilities in respect of Israeli Innovation Authority grants net of current maturities 7,267 6,811
    Liabilities in respect of the purchase of shares 4,998 4,853
    Lease liabilities net of current maturities 1,741 2,006
    Severance pay liability, net 292 243
    Total long term liabilities 15,532 15,048
         
    Shareholders' equity 7,272 15,169
    Total liabilities & shareholder equity 31,070 40,590
         

    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS)

    U.S. dollars in thousands

     Year ended Three months ended
    December 31, December 31,
     2020 2019 2020 2019
            
     AUDITED UNAUDITED
    Revenues21,763  31,789  6,673  5,442 
    Cost of revenues14,218  11,849  4,345  4,360 
    Gross profit 7,545  19,940  2,328  1,082 
    Operating expenses:       
    Research and development, net of participations7,698  4,969  2,225  1,676 
    Selling, general & administrative8,687  9,306  2,489  2,419 
    Other expenses (income), net-  1,172  -  131 
    Total operating expenses16,385  15,447  4,714  4,226 
    Operating profit (loss)(8,840) 4,493  (2,386) (3,144)
    Financial income (expenses), net(436) (2,427) 657  (382)
    Profit (loss) from discontinued operation80  2,889  (3) 83 
    Profit (loss) for the period(9,196) 4,955  (1,732) (3,443)
            
    Foreign currency translation adjustments(23) 8  (12) (9)
    Total comprehensive profit (loss)(9,219) 4,963  (1,744) (3,452)
            
    Profit (loss) per share:       
    Profit (loss) from continuing operations(0.34) 0.08  (0.06) (0.13)
    Profit from discontinued operation-  0.10  -  - 
    Net profit (loss) per share(0.34) 0.18  (0.06) (0.13)
            
    Weighted average number of ordinary shares provided by (used in) the computation of basic and diluted profit (loss) per share (in thousands):27,210  27,203  27,213  27,179 
                

    ADJUSTED EBITDA

    U.S. dollars in thousand

     Year ended Three months ended
     December 31, December 31,
     2020 2019 2020 2019
    Profit (loss) for the period(9,196) 4,955  (1,732) (3,443)
    Adjustments:       
    Financial (expenses) income, net(436) (2,427) 657  (382)
    Profit (loss) from discontinued operation80  2,889  (3) 83 
    Other (expenses) income, net-  (1,172) -  (131)
    Depreciation and amortization(1,090) (1,149) (224) (301)
    Share-based compensation expenses(1,322) (1,234) (399) (303)
    Total adjustments(2,768) (3,093) 31  (1,034)
    Adjusted EBITDA (6,428) 8,048  (1,763) (2,409)
                

    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    U.S. dollars in thousands

     Year ended Three months ended
     December 31, December 31,
     2020 2019 2020 2019
     AUDITED UNAUDITED
    Cash Flows from Operating Activities:       
    Net profit (loss)(9,196) 4,955  (1,732) (3,443)
            
    Adjustments to reconcile net profit (loss) to net cash provided by (used in) continuing operating activities:       
    Adjustments to profit and loss items:       
    Loss (profit)from discontinued operation(80) (2,889) 3  (83)
    Depreciation and amortization1,090  1,149  224  301 
    Share-based compensation1,322  1,234  399  303 
    Revaluation of liabilities in respect of IIA grants828  (392) 136  (293)
    Revaluation of liabilities in respect of purchase of shares(433) 1,690  (991) 171 
    Revaluation of lease liabilities305  340  178  631 
    Increase (decrease) in severance liability, net33  (105) (2) (73)
    Financing income(297) (434) (53) (139)
    Unrealized foreign currency gain(211) (152) (203) (100)
     2,557  441  (309) 718 
    Changes in asset and liability items:       
    Decrease (increase) in trade receivables1,386  (3,553) (91) 402 
    Decrease (increase) in inventories141  67  372  (193)
    Decrease (increase) in other receivables(13) 6,376  384  1,178 
    Increase (decrease) in trade payables & accrued expenses(1,096) 1,355  (171) 1,205 
    Increase (decrease) in other payables & deferred revenues(479) 247  (1,767) (563)
     (61) 4,492  (1,273) 2,029 
    Net cash provided by (used in)   continuing operating activities(6,700) 9,888  (3,314) (696)
    Net cash used in discontinued operating activities(195) (1,599) (3) (1,599)
    Net cash provided by (used in) operating activities(6,895) 8,289  (3,317) (2,295)
            
            
            
            
    Cash Flows from Investment Activities:       
    Purchase of property and equipment(923) (792) (443) (329)
    Interest received274  184  231  80 
    Proceeds from (investment in) short term bank deposits, net of investments18,034  (5,050) 9,898  2,955 
    Net cash provided by (used in) continuing investing activities17,385  (5,658) 9,686  2,706 
    Net cash used in discontinued investing activities-  (1,239) -  (282)
    Net cash provided by (used in) investing activities17,385  (6,897) 9,686  2,424 
    Cash Flows from Financing Activities:       
    Repayment of lease liabilities(508) (630) 25  (729)
    Repayment of IIA grants, net(121) (376) -  - 
    Net cash provided by (used in) financing activities(629) (1,006) 25  (729)
    Exchange rate differences on cash and cash equivalent balances273  140  241  99 
    Increase (decrease) in cash and cash equivalents from continuing activities10,329  3,364  6,638  1,380 
    Decrease in cash and cash equivalents from discontinued activities(195) (2,838) (3) (1,881)
    Balance of cash and cash equivalents at the beginning of the period7,242  6,716  10,741  7,743 
    Balance of cash and cash equivalents at the end of the period17,376  7,242  17,376  7,242 
                

     



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  18. Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin Second Quarter 2021, with Data Expected by the End of 2021

    An Investigator-Initiated Trial Will Run in Parallel

    YAVNE, Israel, Feb. 22, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced the initiation of a new clinical development program to evaluate its drug product candidate MWPC005 in patients with non-melanoma skin cancer. MediWound recently submitted a protocol to the FDA for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma (BCC) and is preparing to initiate this study in the United…

    Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin Second Quarter 2021, with Data Expected by the End of 2021

    An Investigator-Initiated Trial Will Run in Parallel

    YAVNE, Israel, Feb. 22, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced the initiation of a new clinical development program to evaluate its drug product candidate MWPC005 in patients with non-melanoma skin cancer. MediWound recently submitted a protocol to the FDA for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma (BCC) and is preparing to initiate this study in the United States in the second quarter of 2021. A phase II investigator-initiated trial of MWPC005 in non-melanoma skin cancer will be conducted in parallel at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be generated by the end of 2021.

    MWPC005 is a topically applied biological drug candidate based on the same active ingredient as in the Company's NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in bromelain. MediWound's preclinical in-vitro research, combined with existing scientific evidence in a skin cancer model, demonstrated bromelain's anti-cancer activity, and together with clinical case studies suggest that MWPC005 might have a role in treating low-risk non-melanoma skin malignancies.

    "I am pleased to launch our new clinical development program for the treatment of non-melanoma skin cancers. MWPC005 represents an important step in our strategic evolution to leverage our innovative enzymatic platform technology to pioneer solutions for unmet medical needs," said Sharon Malka, Chief Executive Officer of MediWound. "Non-melanoma skin cancers, including BCC, are by far the most common of all types of cancer and represent a significant potential market opportunity. We believe that MWPC005 has the potential to be an effective non-invasive treatment for BCC without the side effects associated with current topical therapies and their longer treatment duration. While MediWound remains focused on its continued growth and advancement of our NexoBrid and EscharEx programs, we are excited to add a synergistic drug product candidate to our pipeline portfolio."

    BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million diagnosed cases every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.

    The phase I/II open-label, randomized clinical study of MWPC005 in BCC is designed to evaluate safety and tolerability using different schedules of administration, as well as provide a preliminary evaluation of efficacy as measured by the percentage of target lesion with complete histological clearance. The study will enroll up to 32 patients with histologically confirmed superficial or nodular BCC and will be conducted at three leading clinical centers in the U.S.

    The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MWPC005 in removing non-melanoma skin cancer and pre-cancerous lesions (e.g. actinic keratosis, BCC and squama cell carcinoma) in up to 50 patients.

    About MWPC005

    MWPC005, is a topically applied biological product candidate based on the same active substance as in NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in Bromelain. MWPC005 is based on a proprietary formulation, designed to ease self-administration by the patients. The clinical development plan of MWPC005 is supported by the results from several toxicological and other preclinical studies, as well as the vast clinical experience from NexoBrid and EscharEx, which share the same active substance.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

    NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. MediWound's third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future preclinical studies and clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com 

     



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  19. YAVNE, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the fourth quarter and year ended December 31, 2020 at 7:00 am Eastern Time on Thursday, February 25, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Thursday, February 25, 2021 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details
    Toll-Free: 877-602-7189
    Israel Toll-Free: 1 809 315 362
    International: 678-894-3057

    YAVNE, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the fourth quarter and year ended December 31, 2020 at 7:00 am Eastern Time on Thursday, February 25, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Thursday, February 25, 2021 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details
    Toll-Free: 877-602-7189
    Israel Toll-Free: 1 809 315 362
    International: 678-894-3057
    Conference ID: 3049108
    Webcast: https://edge.media-server.com/mmc/p/ooo4cb7t

    To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.  An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study. For more information, please visit www.mediwound.com.

    Contacts:    
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
    ir@mediwound.com  jeremy@lifesciadvisors.com 





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  20. YAVNE, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, Chief Executive Officer, will participate in a fireside chat during the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, which is being held February 17-19, 2021.

    Event Details
    Date:Thursday, February 18
    Time:11:30 am ET

    A live webcast of the fireside chat will be available on Events page of the Investors section of the company's website: www.mediwound.com.

    About MediWound Ltd.
    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing…

    YAVNE, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, Chief Executive Officer, will participate in a fireside chat during the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, which is being held February 17-19, 2021.

    Event Details

    Date:Thursday, February 18
    Time:11:30 am ET

    A live webcast of the fireside chat will be available on Events page of the Investors section of the company's website: www.mediwound.com.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx® has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study. For more information, please visit www.mediwound.com.

    Contacts: 
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com



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  21. Phase 2 Adaptive Design Study Sample Size Reduced to 120 Patients

    Interim Assessment Expected in Mid-2021 and Completion of Enrollment by Year-End 2021

    Protocol Submitted to FDA for Pharmacology Clinical Study with Data Expected in Second Half 2021

    YAVNE, Israel, Jan. 11, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on its EscharEx® clinical development program.

    Due to COVID-19 related enrollment delays and potentially future pandemic related implications on the conduct of its clinical studies, the company is accelerating its EscharEx phase 2 adaptive design study…

    Phase 2 Adaptive Design Study Sample Size Reduced to 120 Patients

    Interim Assessment Expected in Mid-2021 and Completion of Enrollment by Year-End 2021

    Protocol Submitted to FDA for Pharmacology Clinical Study with Data Expected in Second Half 2021

    YAVNE, Israel, Jan. 11, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on its EscharEx® clinical development program.

    Due to COVID-19 related enrollment delays and potentially future pandemic related implications on the conduct of its clinical studies, the company is accelerating its EscharEx phase 2 adaptive design study, for the treatment of venous leg ulcers (VLUs), by adjusting its enrollment target to 120 patients, down from the 174 originally planned. The sample size adjustment is supported by the assessment of the positive results generated in a recent in-vivo study, comparing EscharEx to a commercially enzymatic debriding agent, and the debridement efficacy results demonstrated in a previous phase 2 clinical study with first generation EscharEx. The company continues to actively recruit patients and reiterates its expectation for an interim assessment in mid-2021. As a result of the adjustment, study duration is expected to shorten and the company anticipates completing patient enrollment by year-end 2021.

    MediWound recently submitted a protocol to the FDA for a pharmacology study and is preparing to initiate this study in the first half of 2021. The study is an open label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with VLUs or diabetic foot ulcers (DFUs), including the effects on biofilm burden and wound inflammation, as well as the impact of EscharEx on wound healing progression. The company anticipates reporting data from this study in the second half of 2021.

    "We are very pleased with the progress we have made in our EscharEx development program in 2020, despite the challenges posed by the COVID-19 pandemic," said Sharon Malka, Chief Executive Officer of MediWound. "Chronic wounds present a significant unmet medical need for many patients, and we believe that EscharEx can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers. We welcome 2021 with great anticipation and look forward to the pharmacology study data as well as the interim assessment and completion of patient enrollment in our phase 2 adaptive design study."

    About EscharEx

    EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleaves and removes the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment and the completion of enrollment, the time of commencing the pharmacological study and the results , the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid and EscharEx in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com
    Jeremy Feffer

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com



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  22. YAVNE, Israel, Jan. 05, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it will participate in the forthcoming LifeSci Partners 10th Annual Corporate Access Event and the H.C. Wainwright BioConnect 2021 Conference. Both conferences will take place virtually.

    LifeSci Advisors Corporate Access Event (January 6-8 and 11-14)
    Management will be available for virtual 1x1 meetings with institutional investors and sell side analysts. To register for this event and request a meeting, visit: http://lifesci.events/LifeSci2021.

    H.C. Wainwright BioConnect 2021 Conference (January 11-14)
    Management…

    YAVNE, Israel, Jan. 05, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it will participate in the forthcoming LifeSci Partners 10th Annual Corporate Access Event and the H.C. Wainwright BioConnect 2021 Conference. Both conferences will take place virtually.

    LifeSci Advisors Corporate Access Event (January 6-8 and 11-14)

    Management will be available for virtual 1x1 meetings with institutional investors and sell side analysts. To register for this event and request a meeting, visit: http://lifesci.events/LifeSci2021.

    H.C. Wainwright BioConnect 2021 Conference (January 11-14)

    Management will provide a corporate update. The session time is on-demand, beginning Monday January 11 starting 6:00 am (EST). To register and view the presentation, please click here.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of pre-clinical and clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts: 

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

    Jeremy Feffer

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com

     



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  23. YAVNE, Israel, Dec. 21, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the successful completion of a pre-clinical study designed to evaluate the debridement efficacy of EscharEx®, a novel bromelain-based enzymatic debridement agent, in a porcine hard-to-heal wound model, and compare its efficacy with an FDA approved and commercially available collagenase enzymatic debridement agent. The study concluded that EscharEx treatment was more effective than the commercially available collagenase agent in removing eschars in this model. Results from the study will be published in a peer-reviewed…

    YAVNE, Israel, Dec. 21, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the successful completion of a pre-clinical study designed to evaluate the debridement efficacy of EscharEx®, a novel bromelain-based enzymatic debridement agent, in a porcine hard-to-heal wound model, and compare its efficacy with an FDA approved and commercially available collagenase enzymatic debridement agent. The study concluded that EscharEx treatment was more effective than the commercially available collagenase agent in removing eschars in this model. Results from the study will be published in a peer-reviewed journal in the first half of 2021.

    "We are encouraged by the robust results of this in-vivo study comparing EscharEx to the commercially available enzymatic debriding agent," said Sharon Malka, Chief Executive Officer of MediWound. "Given the superior efficacy of EscharEx versus the comparator enzymatic debridement agent demonstrated in this study, as well as the positive safety and efficacy results generated in our previous phase 2 study, we believe EscharEx has the potential to become a game-changer in a sizeable market. EscharEx can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers. We look forward to the publication of these study results in a peer-reviewed journal, and we continue to advance our U.S Phase 2 adaptive design study in venous leg ulcers."

    The study, conducted in collaboration with a U.S. research center, was performed as part of MediWound's pharmacological evaluation of EscharEx's effect on chronic wounds, using a novel porcine eschar model designed to evaluate the efficacy of enzymatic debridement agents. The primary objective of the study was to compare the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic agent (second generation EscharEx formulation), with a commercially available collagenase debridement agent. Efficacy was evaluated based on the number of treatments of various concentrations of EscharEx and the collagenase agent needed to achieve complete eschar removal (greater than 95%), as assessed clinically.

    With EscharEx treatment, complete eschar removal was achieved in all treated wounds, at all dose concentrations, within a maximum of ten 24-hour applications, and dose-dependency was observed in the time to complete debridement. After ten applications, the maximum number of applications needed to achieve complete eschar removal with EscharEx at its lower dose, none of the wounds treated with the collagenase enzymatic agent achieved complete eschar removal.

    About EscharEx

    EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleaves and removes the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of pre-clinical and clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts:Jeremy Feffer
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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  24. YAVNE, Israel, Dec. 14, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has further expanded its NexoBrid® global presence and entered the Middle Eastern markets with the signing of a distribution agreement granting Ghassan Aboud Group (GAG), an international conglomerate based in the United Arab Emirates (UAE), an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns. Commercialization of NexoBrid in the UAE will commence upon securing regulatory approval, which is expected within a year.

    "We are truly excited to partner with GAG to bring NexoBrid…

    YAVNE, Israel, Dec. 14, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has further expanded its NexoBrid® global presence and entered the Middle Eastern markets with the signing of a distribution agreement granting Ghassan Aboud Group (GAG), an international conglomerate based in the United Arab Emirates (UAE), an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns. Commercialization of NexoBrid in the UAE will commence upon securing regulatory approval, which is expected within a year.

    "We are truly excited to partner with GAG to bring NexoBrid to the UAE," said Sharon Malka, Chief Executive Officer of MediWound. "This partnership is an important consequence of the Abraham Accords Peace Agreement signed recently between Israel and the UAE. GAG, through its healthcare arm, Gaelan Medical Trade LLC, has extensive knowledge and experience in wound care and has a strong reach into the major clinical institutions in the UAE. We are proud to enter into our first partnership in the Middle East, and believe that, together with GAG, we will be able to open up new opportunities for NexoBrid across the region, providing burn specialists with a new paradigm for the treatment of severe burns, which can improve patients' lives and the quality of their care."

    Ghassan Aboud, Chairman of Ghassan Aboud Group stated, "We are pleased to partner with MediWound to bring NexoBrid to our markets in the UAE. Our goal is always to pioneer, excel and make an impact, which we have been doing so for 26 years now. I am certain that with our extensive distribution network and market reach, and with MediWound's innovative drug we will be able to improve the standard of care of burn patients and I strongly believe NexoBrid will be an instrumental part of the future treatment for burn patients everywhere."

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel Corporation holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month and twenty-four-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. On September 16, 2020, the FDA accepted for review the Company's Biologics License Application (BLA) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.

    About Ghassan Aboud Group

    Ghassan Aboud Group is an international conglomerate that has been engaged in several key business sectors including health care, automotive, hospitality, real estate, retail, catering, logistics, pastoral, trade and distribution and media for more than two decades.

    Headquartered in the United Arab Emirates, GAG's business operations are complemented by offices in Australia, Belgium, Jordan and Turkey. Ghassan Aboud Group believes that productivity, innovation and transformation require community engagement and ensures that its exclusive portfolio operates in a corporate conscious and a responsible manner making people the number one priority behind its vision "Being at the forefront of excellence".

    Gaelan Medical, GAG's UAE based healthcare and beauty distribution business follows a mission of care and cure and is dedicated to support healthcare providers with world-class solutions to better serve communities across the GCC region. Gaelan medical with its experienced management team, caters to diverse healthcare needs including, pharmaceuticals, medical consumables, medical equipment and beauty products. The company's flexibility and strong financial capabilities of its parent company GAG makes it the preferred partner-of-choice and one stop solution for the region.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts: 
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com 

     



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  25. Total Third Quarter Revenues of $6.6 Million Increased 29% Year-over-Year

    Assigned PDUFA Goal Date of June 29, 2021 for NexoBrid BLA

    YAVNE, Israel, Nov. 10, 2020 (GLOBE NEWSWIRE) --  MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the third quarter ended September 30, 2020.  

    Third Quarter Business and Financial Highlights:

    • Revenues for the third quarter of 2020 were $6.6 million, an increase of 29% compared with the third quarter of 2019, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA)

    • Cash and short term investments…

    Total Third Quarter Revenues of $6.6 Million Increased 29% Year-over-Year

    Assigned PDUFA Goal Date of June 29, 2021 for NexoBrid BLA

    YAVNE, Israel, Nov. 10, 2020 (GLOBE NEWSWIRE) --  MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the third quarter ended September 30, 2020.  

    Third Quarter Business and Financial Highlights:

    • Revenues for the third quarter of 2020 were $6.6 million, an increase of 29% compared with the third quarter of 2019, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA)



    • Cash and short term investments of $25.0 million as of September 30, 2020, compared with $29.5 million as of December 31, 2019



    • Announced the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for NexoBrid and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 29, 2021



    • Delivered the first shipment of NexoBrid to BARDA for emergency response preparedness



    • Completed enrollment stage of the NexoBrid Phase 3 Children Innovation Debridement Study (CIDS). Top-line data anticipated in the second half of 2021



    • Completed U.S Phase 3 (DETECT) including patient long-term safety follow-up; The twenty-four-month safety data of cosmesis and function was comparable across all study arms with no new safety signals observed



    • Continue to address challenges associated with the COVID-19 pandemic, while prioritizing the health and safety of our workforce and maintaining operational efficiency and flexibility

    "We generated strong revenue growth in the third quarter, driven by the first delivery of NexoBrid emergency stock to BARDA," said Sharon Malka, Chief Executive Officer of MediWound. "The quarter was highlighted by several important milestones that bring us closer to our goal of providing a new standard of care for eschar removal in patients with severe burns. Our NexoBrid BLA was accepted for review, we successfully completed the long-term safety patient follow-up stage of our U.S Phase 3 DETECT study, which showed comparable results across all arms, we completed the enrollment stage of our NexoBrid pediatric Phase 3 study and we continue to enroll patients under the NEXT protocol. In addition, we are actively recruiting patients in our U.S. EscharEx® Phase 2 study. While the COVID-19 pandemic continues to cause considerable uncertainty, we expect to maintain growth and are optimistic that we remain on track to strengthen our company further."

    Third Quarter Financial Results

    Revenues for the quarter ended September 30, 2020 were $6.6 million, compared with $5.1million for the third quarter of 2019, an increase of 29%. Revenues from products for the quarter ended September 30, 2020, were $3.2 million, an increase of 189% in comparison to the third quarter of 2019, primarily driven by the procurement of NexoBrid by BARDA for emergency response preparedness.

    Gross profit for the quarter ended September 30, 2020 was $2.8 million, compared with $1.2 million for the third quarter of 2019. Gross margin increased from 23% of revenues in the third quarter of 2019 to 42% in the third quarter of 2020.

    Research and development expenses for the quarter ended September 30, 2020, were $2.1 million, compared with $1.6 million for the third quarter of 2019. The increase was a result of EscharEx clinical development.

    Selling, general and administrative expenses for the quarter ended September 30, 2020 were $2.2 million, in line with the third quarter of 2019.

    Operating loss for the quarter ended September 30, 2020 was $1.5 million, compared with a loss of $2.7 million in the third quarter of 2019.  

    MediWound's loss for the quarter ended September 30, 2020 was $1.9 million, or $0.07 per share, compared with a loss of $0.2 million, or $0.01 per share, for the third quarter of 2019, which included one-time profit from discontinued operations of $2.8 million.

    Adjusted EBITDA, as defined below, for the quarter ended September 30, 2020, was a loss of $0.8 million, compared with a loss of $2.0 million for the third quarter of 2019. 

    Year-to-Date 2020 Financial Results

    Revenues for the nine months ended September 2020 were $15.1 million, compared with $26.3 million in the first nine months of 2019, which included a $17.5 million upfront payment from the Vericel licensing agreement for NexoBrid.

    Operating loss for the nine months ended September 2020 was $6.5 million, compared with a profit of $7.6 million in the comparable period, which includes a $17.5 million upfront license payment and $1.7 million of NexoBrid licensing related expenses. Excluding the upfront license payment, net of deal related costs, operating loss for the first nine months of 2019 was $8.2 million.

    MediWound's loss for the nine months ended September 2020 was $7.5 million, or $0.28 per share, compared with net profit of $8.4 million, or $0.31 per share, for the first nine months of 2019, which included the $17.5 million upfront license payment, $1.7 million licensing deal related expenses and discontinued operating profit of $2.8 million. Excluding the upfront license payment, net of deal related costs, and discontinued profit, net loss for the first nine months of 2019 was $10.2 million, or $0.37 per share.

    Adjusted EBITDA, for the nine months ended September 2020, was a loss of $4.7 million, compared with a profit of $10.5 million for the first nine months of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million.  

    Balance Sheet Highlights

    As of September 30, 2020, MediWound had $25.0 million in cash and short-term investments, compared with $29.5 million as of December 31, 2019, and no debt. MediWound remained on budget, utilizing $4.5 million in the first nine months of 2020 for its operational activities. MediWound reiterates its expectations of cash use for operating activities in 2020 to be in the range of $8 to $10 million. 

    Conference Call

    MediWound management will host a conference call for investors today, Tuesday, November 10, 2020 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.) 1809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 6997223. The call also will be webcast live on the MediWound's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be accessible two hours after its completion through November 24, 2020 by dialing 855-859-2056 (in the U.S.) or 404-537-3406 (outside the U.S.) and entering passcode 6997223. The call will also be archived on MediWound's website for 90 days at www.mediwound.com.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA. Funding and technical support for development of NexoBrid to obtain marketing approval in the U.S. including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; timeline of the 12- and 24-month top-line data in the CIDS; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel Corporation; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid and EscharEx. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts:Jeremy Feffer
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com





    MediWound, Ltd.


    CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands

      Sep 30, Dec 31,
      2020 2019 2019
         
      Un-audited Audited
    Cash, cash equivalents and short term deposits 25,023 32,856 29,458
    Accounts and other receivable 3,495 5,170 4,557
    Inventories 1,805 1,419 1,613
    Total current assets 30,323 39,445 35,628
    LONGTERM ASSETS:      
    Property, plant and equipment, net 2,448 2,169 2,304
    Right of use assets, net 2,170 2,254 2,229
    Intangible assets, net 380 446 429
    Total long term assets 4,998 4,869 4,962
    Total assets 35,321 44,314 40,590
    CURRENT LIABILITIES:      
    Current maturities of long-term liabilities 1,081 810 569
    Trade payables and accrued expenses 3,155 2,863 4,067
    Liability in respect of discontinued Operations - 2,240 -
    Other payables 7,394 4,898 5,737
    Total current liabilities 11,630 10,811 10,373
                 
    Deferred revenues 1,283 1,134 1,135
    Liabilities in respect of Israeli Innovation Authority grants net of current maturities 7,157 7,099 6,811
    Contingent consideration for the purchase of shares net of current maturities 4,408 4,621 4,853
    Lease liabilities net of current maturities 1,942 2,015 2,006
    Severance pay liability, net 284 316 243
    Total long term liabilities 15,074 15,185 15,048
           
    Shareholders' equity 8,617 18,318 15,169
    Total liabilities & shareholder equity 35,321 44,314 40,590



    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED)

    U.S. dollars in thousands

     Nine months ended Three months ended
     Sep 30, Sep 30,
     2020  2019  2020  2019 
            
    Revenues15,090  26,347  6,625  5,140 
    Cost of revenues9,873  7,489  3,855  3,969 
    Gross profit5,217  18,858  2,770  1,171 
    Operating expenses:       
    Research and development, gross5,473  7,861  2,142  1,574 
    Participation by BARDA & IIA-  (4,568)  -  - 
    Research and development, net5,473  3,293  2,142  1,574 
    Selling, general & administrative6,198  6,887  2,170  2,179 
    Other expenses, net-  1,041  -  140 
    Total operating expenses11,671  11,221  4,312  3,893 
    Operating profit (loss)(6,454)  7,637  (1,542)  (2,722) 
            
    Financial expenses, net(1,093)  (2,045)  (448)  (242) 
    Profit (loss) from continuing operations(7,547)  5,592  (1,990)  (2,964) 
    Profit from discontinued operation83  2,806  83  2,756 
    Profit (loss) for the period(7,464)  8,398  (1,907)  (208) 
            
    Foreign currency translation adjustments(11)  17  (12)  15 
    Total comprehensive income (loss)(7,475)  8,415  (1,919)  (193) 
            
    Basic and diluted loss per share:       
    Profit (loss) from continuing operations(0.28)  0.21  (0.07)  (0.11) 
    Profit from discontinued operation(*) 0.10  (*) 0.10 
    Net profit (loss) per share(0.28)  0.31  (0.07)  (0.01) 
    Weighted average number of ordinary shares used in the computation of basic and diluted profit /loss per share:27,206  27,179  27,179  27,179 

    (*) Represents less than $ 1



    MediWound, Ltd.

    ADJUSTED EBITDA

    U.S. dollars in thousands

     Nine months ended Three months ended
    Sep 30, Sep 30,
     2020  2019  2020  2019 
        
     Un-audited Un-audited
    Profit (loss) for the period(7,464)  8,398  (1,907)  (208) 
    Adjustments:       
    Financial expenses, net(1,093)  (2,045)  (448)  (242) 
    Profit from discontinued operation83  2,806  83  2,756 
    Other expenses-  (1,041)  -  (140) 
    Depreciation and amortization(866)  (848)  (327)  (296) 
    Share-based compensation expenses(923)  (931)  (404)  (332) 
    Total adjustments(2,799)  (2,059)  (1,096)  1,746 
    Adjusted EBITDA(4,665)  10,457  (811)  (1,954) 



    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)

    U.S. dollars in thousands

     Nine months ended Three months ended
     Sep 30, Sep 30,
     2020  2019  2020  2019 
    Net profit (loss)(7,464) 8,398  (1,907) (208)
    Adjustments to reconcile net profit (loss) to net cash used in continuing operating activities:       
    Adjustments to profit and loss items:       
    Profit from discontinued operation(83) (2,806) (83) (2,756)
    Depreciation and amortization866  848  327  296 
    Share-based compensation923  931  404  332 
    Revaluation of liabilities in respect of IIA grants692  (99) 268  293 
    Revaluation of contingent consideration for the purchase of shares558  1,519  210  197 
    Revaluation of lease liabilities127  (291) 63  (485)
    Increase (decrease) in severance liability, net35  (32) (5) (22)
    Financing income, net(244) (295) (53) (146)
    Unrealized foreign currency (gain) loss(8) (52) (36) 18 
     2,866  (277) 1,095  (2,273)
    Changes in asset and liability items:       
    Decrease (Increase) in trade receivables1,477  (3,955) 136  (3,946)
    Decrease (increase) in inventories(231) 260  95  114 
    Decrease (increase) in other receivables(397) 5,198  (113) 2,454 
    Increase (decrease) in trade payables and prepaid expenses(925) 150  724  (1,207)
    Increase in other payables & deferred revenues1,288  810  1,202  281 
     Net cash provided by (used in)           

    1,212
      2,463  2,044  (2,304)
    continuing operating activities(3,386) 10,584  1,232  (4,785)
    Net cash provided by discontinued operating activities(192) -  (192) - 
    Net cash provided by (used in) operating activities(3,578) 10,584  1,040  (4,785)



    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)-Cont.

    U.S. dollars in thousands

     Nine months ended Three months ended 
     Sep 30, Sep 30, 
     2020  2019  2020  2019  
    Cash Flows from Investment Activities:        
    Purchase of property and equipment(480) (463) (236) (30) 
    Interest received43  104  1  60  
    Proceeds from short term bank deposits, net of investments8,136  (8,005) (2,459) (10,982) 
    Net cash provided by (used in) continuing investing activities7,699  (8,364) (2,694) (10,952) 
    Net cash used in discontinued investing activities-  (957) -  (1,007) 




    Net cash provided by investing activities
    7,699  (9,321) (2,694) (10,952) 
             
    Cash Flows from Financing Activities:        
    Repayment of lease liabilities(533) 99  (220) 411  
    Proceeds from IIA grants, net of repayments(121) (376) (55) (569) 




    Net cash used in financing activities




    (654




    )
     (277) (275) (158) 
             
    Exchange rate differences on cash and cash equivalent balances32  41  58  (22) 
    Increase (decrease) in cash and cash equivalents from continuing activities3,691  1,984  (1,679) (15,917) 
    Decrease in cash and cash equivalents from discontinued activities(192) (957) (192) (1,007) 
    Balance of cash and cash equivalents at the beginning of the period7,242  6,716  12,612  24,667  
    Balance of cash and cash equivalents at the end of the period10,741   7,743   10,741   7,743   

     

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  26. YAVNE, Israel, Nov. 02, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the third quarter ended September 30, 2020 at 7:00 am Eastern Time on Tuesday, November 10, 2020.

    Following the release, MediWound's management will host a conference call and live webcast on Tuesday, November 10, 2020 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details
    Toll-Free: 877-602-7189
    Israel Toll-Free: 1 809 315 362
    International: 678-894-3057
    Conference

    YAVNE, Israel, Nov. 02, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the third quarter ended September 30, 2020 at 7:00 am Eastern Time on Tuesday, November 10, 2020.

    Following the release, MediWound's management will host a conference call and live webcast on Tuesday, November 10, 2020 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details
    Toll-Free: 877-602-7189
    Israel Toll-Free: 1 809 315 362
    International: 678-894-3057
    Conference ID: 6997223
    Webcast: https://edge.media-server.com/mmc/p/nod4bwun

    To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.  An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com 
     

    Jeremy Feffer

    Managing Director

    LifeSci Advisors, LLC

    jeremy@LifeSciAdvisors.com

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  27. YAVNE, Israel, Oct. 28, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed the enrollment stage of its NexoBrid® Phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study). Top-line results with 12 months follow up data anticipated during the second half of 2021. Additionally, the completion of the CIDS enrollment stage follows the U.S. Food and Drug Administration (FDA)'s recent agreement to allow the NexoBrid expanded access (NEXT) protocol to be expanded to include pediatric as well as adult burn patients.

    "We are pleased to complete the enrollment…

    YAVNE, Israel, Oct. 28, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed the enrollment stage of its NexoBrid® Phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study). Top-line results with 12 months follow up data anticipated during the second half of 2021. Additionally, the completion of the CIDS enrollment stage follows the U.S. Food and Drug Administration (FDA)'s recent agreement to allow the NexoBrid expanded access (NEXT) protocol to be expanded to include pediatric as well as adult burn patients.

    "We are pleased to complete the enrollment stage of our NexoBrid pediatric Phase 3 study, which is one of the most comprehensive randomized controlled studies ever conducted in pediatric burn patients," said Sharon Malka, Chief Executive Officer of MediWound. "The current mode of pediatric burn management requires intensive medical therapy, which poses challenges due to the surgical complexities in treating young patients with severe burns. Having NexoBrid as a non-surgical option, provides a minimally invasive alternative to the current surgical standard of care for treating severe burns in pediatric patients. We look forward to generating top-line results while we expand enrollment in our ongoing NEXT protocol to also include pediatric patients."

    Nick Colangelo, President and CEO of Vericel added, "Completing the enrollment stage of the CIDS study is an important step toward our goal of providing NexoBrid as a treatment option for pediatric patients with severe burns given NexoBrid's potential to address the unique challenges in treating children with severe burns."

    CIDS is a Phase 3, multicenter, multinational, prospective, controlled, assessor-blinded study with 145 patients aged 0-18 years, randomized to be treated with either NexoBrid or standard-of-care, with follow-up periods at 12 months and at 24 months. The study's objectives are to evaluate the efficacy and safety of NexoBrid compared with the standard-of-care in hospitalized children with severe thermal burns of 1 percent to 30 percent Total Body Surface Area (TBSA). The study is being conducted primarily in the U.S. and Europe in accordance with a design and study protocol endorsed by both the European Medicines Agency (EMA) and the U.S. FDA. The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022. The study is fully funded by the Biomedical Advance Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).

    The ongoing NEXT protocol, which is supported and funded by BARDA, enables the continued clinical use of NexoBrid for U.S. patients during the review of the NexoBrid Biologics License Application (BLA). NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate.

    The inclusion of pediatric patients in the NEXT protocol will allow additional physicians to expand their experience with NexoBrid in pediatric patients, ensure burn care preparedness, and expand the national capacity of trained physicians available to treat patients with NexoBrid in a non-declared emergency until the potential approval of the product for pediatric use in the U.S.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. On September 16, 2020, the FDA accepted for review the NexoBrid BLA for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns and assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment. NexoBrid is currently an investigational product in the United States.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States. For more information, refer to www.phe.gov/about/BARDA.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; timeline of the 12- and 24-month data; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study, including the enrollment of pediatric patients; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  

    Specifically, the pandemic may impact the FDA's response times to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts: 
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com

     

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  28. YAVNE, Israel, Oct. 14, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) ("MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it is exploring the pharmacological effect of EscharEx® on biofilm burden associated with chronic wounds based on the scientific evidence showing that enzymatic debridement might be an effective means to treat and reduce the biofilm burden.

    The Unmet Medical Need1

    Biofilms are aggregates of microorganisms encapsulated in a self-created matrix comprised of extracellular polymeric substances (EPS) wherein they are resistant to host defenses and antimicrobial agents. Biofilm…

    YAVNE, Israel, Oct. 14, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) ("MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it is exploring the pharmacological effect of EscharEx® on biofilm burden associated with chronic wounds based on the scientific evidence showing that enzymatic debridement might be an effective means to treat and reduce the biofilm burden.

    The Unmet Medical Need1

    Biofilms are aggregates of microorganisms encapsulated in a self-created matrix comprised of extracellular polymeric substances (EPS) wherein they are resistant to host defenses and antimicrobial agents. Biofilm has been reported to be present in 60%-100% of non-healing wounds and is associated with delayed wound healing, infection and other negative wound healing outcomes. The biofilm treatment market growth is primarily driven by the rising prevalence of chronic, surgical, and traumatic wounds as well by the increasing incidence of burn injuries. North America accounts for the largest share of this market.

    Biofilm is recognized as a local component of the wound environment that requires removal to enable wound progression. Effective surgical debridement and reduction of the biofilm burden is now regarded as a first necessary step in the treatment of chronic wounds such as venous leg ulcers (VLU's), diabetic foot ulcers (DFU's) and pressure ulcers, prior to the application of advanced wound healing materials. While mechanical and surgical methods are commonly used due to their rapidness and specificity, these procedures can be associated with pain, collateral tissue damage, extended hospital stays, and high cost. Enzymatic debridement is an attractive alternative for certain patients because it is less painful, can be applied at the bedside, and has potential effectiveness against a broad range of bacterial wound pathogens.

    As a result, the need for improved biofilm treatment strategies has renewed interest in developing enzymatic compounds for wound debridement and management with the added potential for disruption of EPS.

    The Enzymatic Debridement Opportunity for Degradation of Biofilm

    Multiple preclinical studies have reported that enzymes show promise as an effective treatment for reduction of the biofilm burden independent of its debridement capabilities. A paper published in the journal Infection and Drug Resistance entitled "Enzymatic degradation of in vitro Staphylococcus aureus biofilms supplemented with human plasma," (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4854256/) indicated that bromelain enzyme may be an effective mean of eradicating biofilm and a promising strategy to improve treatment of multidrug-resistant bacterial infections. In addition to removing necrotic tissue, enzymes may possess activity against proteins and bacterial or host DNA within the biofilm matrix.

    EscharEx contains a mixture of proteolytic enzymes enriched in bromelain and has demonstrated in phase 2 clinical trials that it can effectively debride various chronic hard-to-heal wounds, within a few daily applications. Given its protease activity, MediWound believes it has the potential to reduce the biofilm burden by dispersing or inhibiting the formation of the EPS matrix. Therefore, MediWound has initiated plans to conduct pharmacological studies to assess the effect of EscharEx® on biofilm burden associated with chronic wounds.

    "There is a wide consensus among clinicians that biofilm contributes to delays in wound healing. It has been shown that by targeting biofilm, wound healing could be improved," said Dr. Robert Snyder, Chief Medical Director of EscharEx program. "Elevating the standard of care utilizing innovative enzymatic debriding agents such as EscharEx, with the additional potential benefit of disrupting biofilm could provide an improved non-surgical treatment for this malady."

    "The treatment of biofilm in chronic wounds is rapidly becoming a primary objective of wound care, with the presence of biofilm acknowledged as a leading cause of delayed wound healing," said Sharon Malka, Chief Executive Officer of MediWound. "We have reasons to believe that enzymes could become an important treatment in the eradication of biofilms, particularly in chronic wounds, and we believe that a potent, yet convenient, enzymatic debridement agent that can reduce the biofilm burden, could make a major impact on patients and on the worldwide healthcare burden that non-healing wounds cause. We look forward to exploring the effects of EscharEx on biofilm."

    About Biofilm

    Biofilm is created through the attachment of bacteria to elements in the EPS. The EPS, which is 50% to 90% of the total biofilm organic matter, is comprised of dead host tissue, microorganisms' secretions, proteins, nucleic acids, lipids and polysaccharides. Biofilms interfere with normal wound healing, apparently by ‘locking' the wound bed into a chronic inflammatory state that leads to elevated levels of tissue-degrading proteases and reactive oxygen species which damage cells and molecules needed for healing. A large percentage of bacteria in biofilm communities are metabolically dormant, and low metabolic rates make antibiotics ineffective. The EPS substances and their interactions are targets for therapeutic biofilm elimination.

    Bacterial biofilms have been shown to prolong the inflammatory process, which is detrimental to wound healing because of the degradation of the growth factors required for cellular proliferation and migration necessary for wound healing.

    About EscharEx

    EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleaves and removes the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential EscharEx and its potential to reduce the biofilm burden by dispersing or inhibiting the formation of the EPS matrix. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical and pharmacological trials and product development activities; the ability to successfully develop and commercialize EscharEx; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. 

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Certain data in this press release was obtained from various external sources, and neither MediWound nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither MediWound nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or to update such data after the date of this press release. Such data involves risks and uncertainties and is subject to change based on various factors.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.com

    jeremy@lifesciadvisors.com

    1 Source: World Union of Wound Healing Societies (WUWHS), Florence Congress, Position Document. Management of Biofilm. Wounds International 2016 (http://www.wuwhs2016.com/documents)

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  29. YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance…

    YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance of the NexoBrid BLA submission for review is a major milestone for MediWound, and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the United States," said Sharon Malka, CEO of MediWound. "We thank all our partners for their commitment to this important program, and we look forward, together with BARDA and Vericel, to working with the FDA during the regulatory review process as we seek marketing approval for NexoBrid in the United States."

    Nick Colangelo, President and CEO of Vericel, added, "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns and brings us one step closer to providing NexoBrid as a treatment option for the thousands of patients each year who suffer deep-partial and full-thickness burns that require debridement."

    The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. NexoBrid is currently an investigational product in the United States. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    Vericel, our U.S. commercial partner, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid, which will include discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment.

    About MediWound

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA.

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

                           

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com
       

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  30. YAVNE, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, MediWound's Chief Executive Officer, will present at the following investor conferences in September:

    2020 Wells Fargo Virtual Healthcare Conference
    Date: September 10, 2020
    Time: 8:40am ET
    Format: Virtual Presentation

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Time: 11:30am ET
    Format: Virtual Presentation

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date: Monday, September 21, 2020
    Time: 3:20pm ET
    Format: Virtual Presentation…

    YAVNE, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, MediWound's Chief Executive Officer, will present at the following investor conferences in September:

    2020 Wells Fargo Virtual Healthcare Conference

    Date: September 10, 2020

    Time: 8:40am ET

    Format: Virtual Presentation

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14, 2020

    Time: 11:30am ET

    Format: Virtual Presentation

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Monday, September 21, 2020

    Time: 3:20pm ET

    Format: Virtual Presentation

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Contacts: Jeremy Feffer
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
    ir@mediwound.com jeremy@lifesciadvisors.com

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  31. YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds…

    YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. 

    "This first shipment of NexoBrid is another major milestone in our longstanding partnership with BARDA, and we look forward to delivering the full procurement by the end of 2021," said MediWound Chief Executive Officer Sharon Malka. "The acceptance of the first delivery by BARDA during the ongoing COVID-19 pandemic underscores the importance of NexoBrid to U.S. national preparedness for the potential emergency treatment of large numbers of patients with severe thermal burns injuries."

    "The procurement of NexoBrid for our nation's response preparedness is one of many key NexoBrid activities occurring in 2020," said Nick Colangelo, President and Chief Executive Officer of Vericel. "This shipment, combined with the recent BLA submission and growing number of burn centers enrolled in the NexoBrid expanded access treatment protocol, bring us a step closer to ensuring that healthcare providers have both the supply and training needed to enzymatically debride burn patients, whether the need is due to individual accidents or a burn mass casualty event."

    On June 30, 2020, a Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. While the BLA is being reviewed by the FDA, burn centers across the U.S. are treating burn patients under the NexoBrid expanded access (NEXT) protocol.

    The procurement is a key milestone of the Project BioShield (PBS) contract between MediWound and BARDA which was signed in September 2015 with procurement initiated in January 2020. Under the PBS contract, BARDA provides funds and support for the advancement of the development and manufacturing of NexoBrid, as well as the procurement of NexoBrid as a medical countermeasure for mass casualty emergencies involving thermal burns. In May 2019, Vericel entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. As part of the license agreement, Vericel and MediWound will equally split gross profits generated by BARDA's initial $16.5 million procurement.

    In October 2019, MediWound initiated the NEXT protocol, which is supported and funded by BARDA and enables the continued clinical use of NexoBrid for U.S. patients during the preparation and review of the NexoBrid BLA. NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate. MediWound received FDA concurrence that patients can be treated under the NEXT protocol in a burn mass casualty incident that is not a declared national emergency.  Therefore, this provides a mechanism for U.S. burn centers to treat patients and gain valuable experience using Nexobrid prior to FDA approval as well as making the product readily available for response to mass burn emergencies.

    BARDA submitted a Pre-Emergency Use Authorization (PEUA) to FDA for the intended use of NexoBrid under an Emergency Use Authorization (EUA) during a declared emergency involving burn injuries. The availability of medical countermeasures (MCMs), such as Nexobrid, which mitigate preparedness gaps (like debridement and excision steps of burn care) will add to the United States Government's armamentarium for treatment of mass burn casualties. The EUA is a mechanism by which the FDA can allow an unapproved medical product that qualifies as a mass casualty medical countermeasure to be used in a public health emergency.

    About NexoBrid

    NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue.  NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets.  Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area.  The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal.  Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved.  In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed.  On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment. NexoBrid is currently an investigational product in the United States.

    About Vericel Corporation

    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area.  The company also holds an exclusive license for North American commercial rights to NexoBrid, a registration-stage biological orphan product for debridement of severe thermal burns.  For more information, please visit the company's website at www.vcel.com.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    This document contains forward-looking statements, including statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. This release also includes forward-looking statements concerning the objectives and expectations regarding MediWound Ltd. and Vericel Corporation described herein, all of which involve certain risks and uncertainty. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements.

    Among the factors that may result in differences are the inherent uncertainties associated with: the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of our NEXT; the impact of applicable laws and regulations; and the uncer